265 C OPYRIGHT Ó 2014
BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Structural Integrity After Rotator Cuff Repair Does Not Correlate with Patient Function and Pain A Meta-Analysis Robert D. Russell, MD, Justin R. Knight, MD, Edward Mulligan, DPT, and Michael S. Khazzam, MD Investigation performed at the Sports Medicine and Shoulder Service, Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas
Background: The correlation between the structural integrity of rotator cuff repair and the clinical outcome for the patient remains controversial. The purpose of this study was to assess the relationship between patient function and structural integrity of the rotator cuff after repair. Methods: A systematic review and a meta-analysis were conducted for Level-I and Level-II studies showing outcome measures after rotator cuff repair and an imaging assessment of the structural integrity of the repair. Data extracted included patient demographics, tear size, repair type, clinical outcome measures, and repair integrity. Statistical analysis was performed to compare outcomes in patients on the basis of the structural integrity of repair at the time of the latest follow-up. Results: Fourteen studies met inclusion criteria and were included in the latest analysis. Of the 861 patients who underwent rotator cuff repair with a minimum of a one-year follow-up, 674 patients (78.3%) had intact repairs at the time of latest follow-up. There was no difference in tear size between patients with intact repairs and those with retears (p = 0.866). The University of California Los Angeles shoulder score, the Constant score, and the American Shoulder and Elbow Surgeons score increased and the visual analog scale score decreased in patients regardless of the structural integrity of the repair. Patients with intact repairs had higher Constant scores by 8.93 points (p < 0.0001) and higher University of California Los Angeles shoulder scores by 2.95 points (p = 0.0004). Postoperative American Shoulder and Elbow Surgeons scores were no different in patients with intact repairs or retears (p = 0.15). Postoperative visual analog scale scores were 0.93 points lower in patients with intact repairs (p = 0.01). Patients with intact repairs had increased strength in forward elevation by 2.40 kilograms (5.29 pounds) (p < 0.00001) and had a trend toward increased strength in shoulder external rotation (p = 0.06). Although these results are significant, the differences are not clinically important on the basis of the validation of these outcome measures. Conclusions: The results of this study suggest that there is not a clinically important difference in validated functional outcome scores or pain for patients who have undergone rotator cuff repair regardless of the structural integrity of the repair. Patients with intact repairs do have significantly greater strength than those with retears. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
J Bone Joint Surg Am. 2014;96:265-71
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http://dx.doi.org/10.2106/JBJS.M.00265
A commentary by Brian R. Wolf, MD, MS, is linked to the online version of this article at jbjs.org.
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otator cuff repair can reliably decrease pain and can improve shoulder function. Excellent clinical results have been reported for a variety of techniques1-5. Biomechanical studies have demonstrated that improved repair techniques result in stronger initial fixation of the repair, and many surmise that this leads to improved healing of the rotator cuff 6,7. This result has sparked interest in evaluating whether structural integrity of the repair correlates with patients’ clinical outcome. Despite the evolution of repair techniques, the rate of unhealed or retorn cuffs after repair remains relatively high2,8-20. Regardless of the repair technique, recurrent rotator cuff tears or repair failures are seen in 20% to 94% of patients21-24. Furthermore, previous work attempting to correlate structural integrity of the rotator cuff to patient outcome after rotator cuff repair has not demonstrated definitive results21. Several studies have shown improved patient outcomes for patients who have intact repairs on postoperative imaging25-29. Harryman et al. reported that patients with intact repairs had increased function and shoulder motion compared with patients with persistent defects26. Nho et al. demonstrated that patients with intact repairs had increased strength in external rotation and had a difference in American Shoulder and Elbow Surgeons (ASES) scores that neared significance29. Similarly, Boileau et al. demonstrated that patients with intact repairs had increased strength in forward elevation25. Levy et al. reported higher postoperative Constant scores, lower overall pain, and increased shoulder abduction strength in patients with intact repairs28. However, a recurrent defect is not necessarily correlated with a poor functional outcome. Many authors have demonstrated no difference in patient outcomes between patients with an intact repair and those with repairs with structural failure on postoperative imaging21. Galatz et al. performed a study on massive rotator cuff tears repaired arthroscopically and demonstrated that the average ASES score improved from 48.3 points preoperatively to 84.6 points postoperatively, despite a 94% rate of retear21. Akpinar et al. demonstrated no difference in postoperative University of California Los Angeles (UCLA) shoulder scores or Constant scores, despite a 34.6% rate of structural defects24. Slabaugh et al. performed a systematic review to correlate structural integrity to patient outcome and demonstrated that patients with intact repairs had increased strength and motion in forward elevation27. That study included only Level-IV studies and did not demonstrate a conclusive difference between patients with intact repairs and those without. The purpose of the current study was to review the highest level of evidence available, reporting both the structural integrity of the rotator cuff and the patient outcome assessment after rotator cuff repair. The hypothesis of this study was that there is no difference in clinical outcomes following rotator cuff repair between patients with intact repairs and those with failure on postoperative imaging.
I N T E G R I T Y O F R O TAT O R C U F F R E PA I R D O E S N O T C O R R E L AT E W I T H O U T C O M E
articles showing structural integrity and clinical outcomes in patients undergoing rotator cuff repair. The following search terms were used: ‘‘rotator cuff tear,’’ ‘‘supraspinatus tear,’’ ‘‘rotator cuff AND repair,’’ ‘‘rotator cuff AND repair AND healing,’’ ‘‘rotator cuff AND repair AND outcome,’’ and ‘‘rotator cuff AND repair AND imaging.’’ Inclusion criteria were peer-reviewed articles published in the English language prior to July 2012. To be included, a study had to show at least one outcome measure after rotator cuff repair and had to show an assessment of the structural integrity of the repair by magnetic resonance imaging (MRI), computed tomographic (CT) arthrography, or ultrasound. The minimum required follow-up was one year. Only Level-I and Level-II studies were included. The level of evidence was determined by two independent reviewers (R.D.R. and J.R.K.), and disputes were settled by a third reviewer (M.S.K.). Exclusion criteria were studies that were Level III or lower, included only massive rotator cuff tears, included partial-thickness rotator cuff tears, and used platelet-rich plasma or graft augmentation. No requirements were placed on the surgical technique of rotator cuff repair. Titles from all articles meeting search criteria were reviewed by two independent reviewers. Studies that were clearly not related to our research question were immediately excluded. The abstracts of all studies that were not excluded by title were reviewed and were excluded on the basis of the criteria mentioned above. If it was unclear whether a study met criteria on the basis of the abstract alone, the methods section of the article was reviewed. At this point, the full text of all remaining studies was reviewed (Fig. 1). For all included studies, data were extracted from the articles that included patient demographics, tear size, type of repair, clinical outcome measures, and structural integrity of the repairs based on imaging. If these data were not available, the authors of each article were contacted and we requested the radiographic and clinical outcome data for each patient in the study. Articles that did not have this information included or whose authors did not provide it after our request were excluded from the metaanalysis. Analysis was performed separately for each of the reported outcomes measures (ASES, Constant, and UCLA). The Coleman Methodology Score (CMS) was used to assess the methodological quality of each included study, as described by the Consolidated Standards of Reporting Trials (CONSORT) 30 guidelines . A meta-analysis was performed to compare the clinical results to imaging of patients from the included studies. Patients were defined as having a retear after repair if postoperative imaging demonstrated a fullthickness, structural tear of the rotator cuff. Postoperative partial-thickness
Materials and Methods
A
comprehensive search of peer-reviewed literature was performed with use of the search engines CINAHL, PubMed, and MEDLINE to identify
Fig. 1
Flowchart describing the process of study selection and exclusion.
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tears were considered intact. For each available outcome measure, studies were pooled and patients were divided into two groups: those with an intact repair and those with a retear. Statistical analysis was performed to evaluate for any difference in outcomes for patients who had intact repairs compared with patients who did not have intact repairs at the time of the latest follow-up.
Statistical Analysis Differences between groups were assessed with use of the t test. Pooled outcomes data for the meta-analysis were analyzed. All outcome scores were continuous variables, and the weighted mean difference with 95% confidence intervals (CIs) were calculated for each outcome score between patients with intact repairs and those with retears using a random effects model. Significance was set at p £ 0.05.
Source of Funding
I N T E G R I T Y O F R O TAT O R C U F F R E PA I R D O E S N O T C O R R E L AT E W I T H O U T C O M E
of single-row and double-row rotator cuff repair, one study compared open and arthroscopic repair, one study compared Mason-Allen and Kessler suture repair, one study compared a modified mattress locking stitch and a simple stitch, one study compared single-tendon repair and two-tendon repair, one study compared double-row repair and suture-bridge repair techniques, one study compared postoperative rehabilitation protocols, one study was an arthroscopic repair cohort, and one study was an open repair cohort. The average patient age for all included studies was 58.5 years, and the average followup was 30.1 months, with an overall follow-up rate of 79.4%. In nine of the studies, an a priori power analysis was performed to ensure that the study was adequately powered (see Appendix).
No external funding was received for this study.
Results Literature Search total of twenty-two articles were included for full-text review, and fourteen studies met the final inclusion criteria for the systematic review. Of the fourteen studies, sufficient data to complete the meta-analysis were present in four. After contacting the authors of the remaining studies, we received responses with data from three authors, for a total of seven studies included in the final meta-analysis. Figure 1 describes the process by which we selected articles for the systematic review and meta-analysis. Four studies were included in the meta-analysis pooling Constant score data 8,15,17,18, four studies were included in the meta-analysis pooling UCLA data13,15,17,19, five studies were included in the meta-analysis pooling ASES data 8,14,15,17,18, three studies were included in the meta-analysis pooling visual analog scale (VAS) data8,15,17, two studies were included in the meta-analysis pooling external rotation strength data8,15, and three studies were included in the meta-analysis pooling forward elevation strength data8,14,18. Five studies had a Level-I level of evidence and nine studies had a Level-II level of evidence. All studies were published between 2004 and 2012. Eight studies were randomized controlled trials and six studies were prospective cohort studies. The average CMS of the studies was 83.5 points (range, 68 to 100 points). Six studies compared the results
A
Outcome on Imaging Studies Imaging data on the structural integrity of the rotator cuff were available for all fourteen studies. The time between rotator cuff repair and postoperative imaging ranged from six to thirty-six months. Seven of the studies performed postoperative imaging using non-contrast MRI, two studies used MR arthrography, two studies used ultrasound, and one study used CT arthrography. Two of the studies used a combination of MRI and ultrasound. Of the 861 patients who underwent rotator cuff repair, 674 (78.3%) had repairs that were intact on postoperative imaging. The percent of patients with intact rotator cuffs on postoperative imaging varied among studies from 59.7% to 94.2% of patients. The average reported preoperative tear size was 2.68 cm. There was no difference (p = 0.87) in the preoperative tear size for patients with an intact repair (2.67 ± 1.5 cm) compared with patients with a retear (2.72 ± 1.4 cm). Clinical Outcome Scores The average UCLA, Constant, and ASES scores increased and the VAS score decreased in patients regardless of the structural integrity of the repair. Patients with intact repairs had higher postoperative Constant scores at 8.93 points (95% CI, 4.52 to 13.34 points; p < 0.0001) (Fig. 2) and higher UCLA scores at 2.95 points (95% CI, 1.33 to 4.57 points; p = 0.0004) (Fig. 3), but they did not have significantly
Fig. 2
Meta-analysis of the Constant score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio.
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Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 3 Meta-analysis of the UCLA score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio. Fig. 4 Meta-analysis of the ASES score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio. Fig. 5 Meta-analysis of the VAS pain score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = MantelHaenszel odds ratio. Fig. 6 Meta-analysis of external rotation strength in pounds comparing patients who had intact repairs with those who had retears. The mean difference was 6.78 pounds (95% CI, 20.39 to 13.95 pounds) (3.08 kg [95% CI, 20.18 to 6.33 kg]). SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio.
higher postoperative ASES scores at 5.17 points (95% CI, 21.92 to 12.27 points; p = 0.15) (Fig. 4). Patients with intact repairs had lower postoperative VAS scores at 20.93 points (95% CI, 21.66 to 20.21 points; p = 0.01) (Fig. 5), and they had a trend (p = 0.06) toward increased strength in shoulder external rotation at 3.08 kg (95% CI, 20.18 to 6.33 kg) (6.78 pounds [95% CI, 20.39 to 13.95 pounds]) (Fig. 6).
Patients with an intact repair had a significant difference (p < 0.00001) with regard to higher strength in forward elevation at 2.40 kg (95% CI, 1.52 to 3.28 kg) (5.29 pounds [95% CI, 3.34 to 7.24 pounds]) (Fig. 7). Although these results are significant, the differences are not clinically important on the basis of the validation of these outcome measures.
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Fig. 7
Meta-analysis of forward elevation strength in pounds comparing patients who had intact repairs with those who had retears. The mean difference was 5.29 pounds (95% CI, 3.34 to 7.24 pounds) (2.40 kg [95% CI, 1.52 to 3.28 kg]). SD = standard deviation, df = degrees of freedom, and IV = MantelHaenszel odds ratio.
Discussion otator cuff repair is a common procedure that generally results in a predictable improvement in patient function and decreased pain. However, persistent tears or retear after rotator cuff repair are not uncommon2,8,10,11,13-16,18-20. It has been well established that factors such as tear size, fatty infiltration, and muscle atrophy influence healing rates following rotator cuff repair. Several authors31-34 demonstrated that the degree of fatty infiltration and muscular atrophy prior to repair correlate with outcome and higher Goutallier34 grades (2 and above) can be expected to progress even in rotator cuff tears that heal. Additionally, fatty infiltration and muscle atrophy are irreversible changes despite successful tendon-to-bone healing, and those repairs that fail can be expected to progress. Gladstone et al.31 also demonstrated that there is a point of no return where muscle undergoes irreversible structural changes and the identification of this time point is helpful in predicting clinical and structural outcome. Over the past decade, many new surgical techniques have been developed to increase the strength of initial fixation after rotator cuff repair with the goal of increasing healing. Despite increased repair strength with modern surgical techniques, as demonstrated in biomechanical studies6,7,35, the failure of healing after rotator cuff repair has been reported to be as high as 40%2,8,10-14,16,17,19. Furthermore, the relationship between the structural integrity of the repair and clinical outcome for patients undergoing rotator cuff repair is unclear. A possible explanation may be that most authors report statistical differences but do not consider whether those differences are clinically relevant. The results of this meta-analysis demonstrate that the structural integrity does not correlate with a clinically important difference in patient function and pain relief after rotator cuff repair. Although there were significant differences in patient outcomes, these results do not appear to meet the criteria for clinical importance. The ASES score has been validated as an outcome measure in patients with shoulder pathology, including rotator cuff tears36. The minimal clinically important difference in the ASES score has been reported to be in the range of 6.4 to 12.00 36-38. In this meta-analysis, the difference in the ASES scores for patients with intact rotator cuffs was not significantly different from the scores for patients with retears.
R
In patients being treated for rotator cuff disease, the minimal clinically important difference for VAS has been reported to be 1.4 points on a scale of 1 to 10 points39. Moreover, the same study showed the patient acceptable symptomatic state to be 3 points on a 10-point VAS. The results of our analysis demonstrated that the VAS for all patients was
BY
T HE J OURNAL
OF
B ONE
AND J OINT
S URGERY, I NCORPORATED
Structural Integrity After Rotator Cuff Repair Does Not Correlate with Patient Function and Pain A Meta-Analysis Robert D. Russell, MD, Justin R. Knight, MD, Edward Mulligan, DPT, and Michael S. Khazzam, MD Investigation performed at the Sports Medicine and Shoulder Service, Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas
Background: The correlation between the structural integrity of rotator cuff repair and the clinical outcome for the patient remains controversial. The purpose of this study was to assess the relationship between patient function and structural integrity of the rotator cuff after repair. Methods: A systematic review and a meta-analysis were conducted for Level-I and Level-II studies showing outcome measures after rotator cuff repair and an imaging assessment of the structural integrity of the repair. Data extracted included patient demographics, tear size, repair type, clinical outcome measures, and repair integrity. Statistical analysis was performed to compare outcomes in patients on the basis of the structural integrity of repair at the time of the latest follow-up. Results: Fourteen studies met inclusion criteria and were included in the latest analysis. Of the 861 patients who underwent rotator cuff repair with a minimum of a one-year follow-up, 674 patients (78.3%) had intact repairs at the time of latest follow-up. There was no difference in tear size between patients with intact repairs and those with retears (p = 0.866). The University of California Los Angeles shoulder score, the Constant score, and the American Shoulder and Elbow Surgeons score increased and the visual analog scale score decreased in patients regardless of the structural integrity of the repair. Patients with intact repairs had higher Constant scores by 8.93 points (p < 0.0001) and higher University of California Los Angeles shoulder scores by 2.95 points (p = 0.0004). Postoperative American Shoulder and Elbow Surgeons scores were no different in patients with intact repairs or retears (p = 0.15). Postoperative visual analog scale scores were 0.93 points lower in patients with intact repairs (p = 0.01). Patients with intact repairs had increased strength in forward elevation by 2.40 kilograms (5.29 pounds) (p < 0.00001) and had a trend toward increased strength in shoulder external rotation (p = 0.06). Although these results are significant, the differences are not clinically important on the basis of the validation of these outcome measures. Conclusions: The results of this study suggest that there is not a clinically important difference in validated functional outcome scores or pain for patients who have undergone rotator cuff repair regardless of the structural integrity of the repair. Patients with intact repairs do have significantly greater strength than those with retears. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
Peer Review: This article was reviewed by the Editor-in-Chief and one Deputy Editor, and it underwent blinded review by two or more outside experts. It was also reviewed by an expert in methodology and statistics. The Deputy Editor reviewed each revision of the article, and it underwent a final review by the Editor-in-Chief prior to publication. Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.
J Bone Joint Surg Am. 2014;96:265-71
d
http://dx.doi.org/10.2106/JBJS.M.00265
A commentary by Brian R. Wolf, MD, MS, is linked to the online version of this article at jbjs.org.
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otator cuff repair can reliably decrease pain and can improve shoulder function. Excellent clinical results have been reported for a variety of techniques1-5. Biomechanical studies have demonstrated that improved repair techniques result in stronger initial fixation of the repair, and many surmise that this leads to improved healing of the rotator cuff 6,7. This result has sparked interest in evaluating whether structural integrity of the repair correlates with patients’ clinical outcome. Despite the evolution of repair techniques, the rate of unhealed or retorn cuffs after repair remains relatively high2,8-20. Regardless of the repair technique, recurrent rotator cuff tears or repair failures are seen in 20% to 94% of patients21-24. Furthermore, previous work attempting to correlate structural integrity of the rotator cuff to patient outcome after rotator cuff repair has not demonstrated definitive results21. Several studies have shown improved patient outcomes for patients who have intact repairs on postoperative imaging25-29. Harryman et al. reported that patients with intact repairs had increased function and shoulder motion compared with patients with persistent defects26. Nho et al. demonstrated that patients with intact repairs had increased strength in external rotation and had a difference in American Shoulder and Elbow Surgeons (ASES) scores that neared significance29. Similarly, Boileau et al. demonstrated that patients with intact repairs had increased strength in forward elevation25. Levy et al. reported higher postoperative Constant scores, lower overall pain, and increased shoulder abduction strength in patients with intact repairs28. However, a recurrent defect is not necessarily correlated with a poor functional outcome. Many authors have demonstrated no difference in patient outcomes between patients with an intact repair and those with repairs with structural failure on postoperative imaging21. Galatz et al. performed a study on massive rotator cuff tears repaired arthroscopically and demonstrated that the average ASES score improved from 48.3 points preoperatively to 84.6 points postoperatively, despite a 94% rate of retear21. Akpinar et al. demonstrated no difference in postoperative University of California Los Angeles (UCLA) shoulder scores or Constant scores, despite a 34.6% rate of structural defects24. Slabaugh et al. performed a systematic review to correlate structural integrity to patient outcome and demonstrated that patients with intact repairs had increased strength and motion in forward elevation27. That study included only Level-IV studies and did not demonstrate a conclusive difference between patients with intact repairs and those without. The purpose of the current study was to review the highest level of evidence available, reporting both the structural integrity of the rotator cuff and the patient outcome assessment after rotator cuff repair. The hypothesis of this study was that there is no difference in clinical outcomes following rotator cuff repair between patients with intact repairs and those with failure on postoperative imaging.
I N T E G R I T Y O F R O TAT O R C U F F R E PA I R D O E S N O T C O R R E L AT E W I T H O U T C O M E
articles showing structural integrity and clinical outcomes in patients undergoing rotator cuff repair. The following search terms were used: ‘‘rotator cuff tear,’’ ‘‘supraspinatus tear,’’ ‘‘rotator cuff AND repair,’’ ‘‘rotator cuff AND repair AND healing,’’ ‘‘rotator cuff AND repair AND outcome,’’ and ‘‘rotator cuff AND repair AND imaging.’’ Inclusion criteria were peer-reviewed articles published in the English language prior to July 2012. To be included, a study had to show at least one outcome measure after rotator cuff repair and had to show an assessment of the structural integrity of the repair by magnetic resonance imaging (MRI), computed tomographic (CT) arthrography, or ultrasound. The minimum required follow-up was one year. Only Level-I and Level-II studies were included. The level of evidence was determined by two independent reviewers (R.D.R. and J.R.K.), and disputes were settled by a third reviewer (M.S.K.). Exclusion criteria were studies that were Level III or lower, included only massive rotator cuff tears, included partial-thickness rotator cuff tears, and used platelet-rich plasma or graft augmentation. No requirements were placed on the surgical technique of rotator cuff repair. Titles from all articles meeting search criteria were reviewed by two independent reviewers. Studies that were clearly not related to our research question were immediately excluded. The abstracts of all studies that were not excluded by title were reviewed and were excluded on the basis of the criteria mentioned above. If it was unclear whether a study met criteria on the basis of the abstract alone, the methods section of the article was reviewed. At this point, the full text of all remaining studies was reviewed (Fig. 1). For all included studies, data were extracted from the articles that included patient demographics, tear size, type of repair, clinical outcome measures, and structural integrity of the repairs based on imaging. If these data were not available, the authors of each article were contacted and we requested the radiographic and clinical outcome data for each patient in the study. Articles that did not have this information included or whose authors did not provide it after our request were excluded from the metaanalysis. Analysis was performed separately for each of the reported outcomes measures (ASES, Constant, and UCLA). The Coleman Methodology Score (CMS) was used to assess the methodological quality of each included study, as described by the Consolidated Standards of Reporting Trials (CONSORT) 30 guidelines . A meta-analysis was performed to compare the clinical results to imaging of patients from the included studies. Patients were defined as having a retear after repair if postoperative imaging demonstrated a fullthickness, structural tear of the rotator cuff. Postoperative partial-thickness
Materials and Methods
A
comprehensive search of peer-reviewed literature was performed with use of the search engines CINAHL, PubMed, and MEDLINE to identify
Fig. 1
Flowchart describing the process of study selection and exclusion.
267 TH E JO U R NA L O F B O N E & JO I N T SU RG E RY J B J S . O RG V O L U M E 96-A N U M B E R 4 F E B R UA R Y 19, 2 014 d
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tears were considered intact. For each available outcome measure, studies were pooled and patients were divided into two groups: those with an intact repair and those with a retear. Statistical analysis was performed to evaluate for any difference in outcomes for patients who had intact repairs compared with patients who did not have intact repairs at the time of the latest follow-up.
Statistical Analysis Differences between groups were assessed with use of the t test. Pooled outcomes data for the meta-analysis were analyzed. All outcome scores were continuous variables, and the weighted mean difference with 95% confidence intervals (CIs) were calculated for each outcome score between patients with intact repairs and those with retears using a random effects model. Significance was set at p £ 0.05.
Source of Funding
I N T E G R I T Y O F R O TAT O R C U F F R E PA I R D O E S N O T C O R R E L AT E W I T H O U T C O M E
of single-row and double-row rotator cuff repair, one study compared open and arthroscopic repair, one study compared Mason-Allen and Kessler suture repair, one study compared a modified mattress locking stitch and a simple stitch, one study compared single-tendon repair and two-tendon repair, one study compared double-row repair and suture-bridge repair techniques, one study compared postoperative rehabilitation protocols, one study was an arthroscopic repair cohort, and one study was an open repair cohort. The average patient age for all included studies was 58.5 years, and the average followup was 30.1 months, with an overall follow-up rate of 79.4%. In nine of the studies, an a priori power analysis was performed to ensure that the study was adequately powered (see Appendix).
No external funding was received for this study.
Results Literature Search total of twenty-two articles were included for full-text review, and fourteen studies met the final inclusion criteria for the systematic review. Of the fourteen studies, sufficient data to complete the meta-analysis were present in four. After contacting the authors of the remaining studies, we received responses with data from three authors, for a total of seven studies included in the final meta-analysis. Figure 1 describes the process by which we selected articles for the systematic review and meta-analysis. Four studies were included in the meta-analysis pooling Constant score data 8,15,17,18, four studies were included in the meta-analysis pooling UCLA data13,15,17,19, five studies were included in the meta-analysis pooling ASES data 8,14,15,17,18, three studies were included in the meta-analysis pooling visual analog scale (VAS) data8,15,17, two studies were included in the meta-analysis pooling external rotation strength data8,15, and three studies were included in the meta-analysis pooling forward elevation strength data8,14,18. Five studies had a Level-I level of evidence and nine studies had a Level-II level of evidence. All studies were published between 2004 and 2012. Eight studies were randomized controlled trials and six studies were prospective cohort studies. The average CMS of the studies was 83.5 points (range, 68 to 100 points). Six studies compared the results
A
Outcome on Imaging Studies Imaging data on the structural integrity of the rotator cuff were available for all fourteen studies. The time between rotator cuff repair and postoperative imaging ranged from six to thirty-six months. Seven of the studies performed postoperative imaging using non-contrast MRI, two studies used MR arthrography, two studies used ultrasound, and one study used CT arthrography. Two of the studies used a combination of MRI and ultrasound. Of the 861 patients who underwent rotator cuff repair, 674 (78.3%) had repairs that were intact on postoperative imaging. The percent of patients with intact rotator cuffs on postoperative imaging varied among studies from 59.7% to 94.2% of patients. The average reported preoperative tear size was 2.68 cm. There was no difference (p = 0.87) in the preoperative tear size for patients with an intact repair (2.67 ± 1.5 cm) compared with patients with a retear (2.72 ± 1.4 cm). Clinical Outcome Scores The average UCLA, Constant, and ASES scores increased and the VAS score decreased in patients regardless of the structural integrity of the repair. Patients with intact repairs had higher postoperative Constant scores at 8.93 points (95% CI, 4.52 to 13.34 points; p < 0.0001) (Fig. 2) and higher UCLA scores at 2.95 points (95% CI, 1.33 to 4.57 points; p = 0.0004) (Fig. 3), but they did not have significantly
Fig. 2
Meta-analysis of the Constant score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio.
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Fig. 3 Meta-analysis of the UCLA score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio. Fig. 4 Meta-analysis of the ASES score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio. Fig. 5 Meta-analysis of the VAS pain score comparing patients who had intact repairs with those who had retears. SD = standard deviation, df = degrees of freedom, and IV = MantelHaenszel odds ratio. Fig. 6 Meta-analysis of external rotation strength in pounds comparing patients who had intact repairs with those who had retears. The mean difference was 6.78 pounds (95% CI, 20.39 to 13.95 pounds) (3.08 kg [95% CI, 20.18 to 6.33 kg]). SD = standard deviation, df = degrees of freedom, and IV = Mantel-Haenszel odds ratio.
higher postoperative ASES scores at 5.17 points (95% CI, 21.92 to 12.27 points; p = 0.15) (Fig. 4). Patients with intact repairs had lower postoperative VAS scores at 20.93 points (95% CI, 21.66 to 20.21 points; p = 0.01) (Fig. 5), and they had a trend (p = 0.06) toward increased strength in shoulder external rotation at 3.08 kg (95% CI, 20.18 to 6.33 kg) (6.78 pounds [95% CI, 20.39 to 13.95 pounds]) (Fig. 6).
Patients with an intact repair had a significant difference (p < 0.00001) with regard to higher strength in forward elevation at 2.40 kg (95% CI, 1.52 to 3.28 kg) (5.29 pounds [95% CI, 3.34 to 7.24 pounds]) (Fig. 7). Although these results are significant, the differences are not clinically important on the basis of the validation of these outcome measures.
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Meta-analysis of forward elevation strength in pounds comparing patients who had intact repairs with those who had retears. The mean difference was 5.29 pounds (95% CI, 3.34 to 7.24 pounds) (2.40 kg [95% CI, 1.52 to 3.28 kg]). SD = standard deviation, df = degrees of freedom, and IV = MantelHaenszel odds ratio.
Discussion otator cuff repair is a common procedure that generally results in a predictable improvement in patient function and decreased pain. However, persistent tears or retear after rotator cuff repair are not uncommon2,8,10,11,13-16,18-20. It has been well established that factors such as tear size, fatty infiltration, and muscle atrophy influence healing rates following rotator cuff repair. Several authors31-34 demonstrated that the degree of fatty infiltration and muscular atrophy prior to repair correlate with outcome and higher Goutallier34 grades (2 and above) can be expected to progress even in rotator cuff tears that heal. Additionally, fatty infiltration and muscle atrophy are irreversible changes despite successful tendon-to-bone healing, and those repairs that fail can be expected to progress. Gladstone et al.31 also demonstrated that there is a point of no return where muscle undergoes irreversible structural changes and the identification of this time point is helpful in predicting clinical and structural outcome. Over the past decade, many new surgical techniques have been developed to increase the strength of initial fixation after rotator cuff repair with the goal of increasing healing. Despite increased repair strength with modern surgical techniques, as demonstrated in biomechanical studies6,7,35, the failure of healing after rotator cuff repair has been reported to be as high as 40%2,8,10-14,16,17,19. Furthermore, the relationship between the structural integrity of the repair and clinical outcome for patients undergoing rotator cuff repair is unclear. A possible explanation may be that most authors report statistical differences but do not consider whether those differences are clinically relevant. The results of this meta-analysis demonstrate that the structural integrity does not correlate with a clinically important difference in patient function and pain relief after rotator cuff repair. Although there were significant differences in patient outcomes, these results do not appear to meet the criteria for clinical importance. The ASES score has been validated as an outcome measure in patients with shoulder pathology, including rotator cuff tears36. The minimal clinically important difference in the ASES score has been reported to be in the range of 6.4 to 12.00 36-38. In this meta-analysis, the difference in the ASES scores for patients with intact rotator cuffs was not significantly different from the scores for patients with retears.
R
In patients being treated for rotator cuff disease, the minimal clinically important difference for VAS has been reported to be 1.4 points on a scale of 1 to 10 points39. Moreover, the same study showed the patient acceptable symptomatic state to be 3 points on a 10-point VAS. The results of our analysis demonstrated that the VAS for all patients was
