http://informahealthcare.com/mor ISSN 1439-7595 (print), 1439-7609 (online) Mod Rheumatol, 2015; 25(3): 362–366 © 2014 Japan College of Rheumatology DOI: 10.3109/14397595.2014.956984

ORIGINAL ARTICLE

Preference of surgical procedure for the forefoot deformity in the rheumatoid arthritis patients—A prospective, randomized, internal controlled study Masahiro Tada1, Tatsuya Koike2,4, Tadashi Okano1, Yuko Sugioka2, Shigeyuki Wakitani1, Kenji Mamoto1, Kentaro Inui3, and Hiroaki Nakamura1 1Departments of Orthopaedic Surgery, Osaka City University Medical School, Osaka, Japan, 2Center for Senile Degenerative Disorders,

Osaka City University Medical School, Osaka, Japan, 3Department of Rheumatosurgery, Osaka City University Medical School, Osaka, Japan, and 4Search Institute for Bone and Arthritis Disease, Shirahama Foundation for Health and Welfare, Wakayama, Japan

Abstract

Keywords

Objectives. The deformed rheumatoid forefoot may be treated with resection of lesser metatarsal heads combined with arthrodesis or resection of the first metatarsophalangeal joint. Recurrent hallux valgus deformity has been reported by resection. We performed a prospective, randomized, internal-controlled study to compare results between arthrodesis and resection. Methods. We resected the lesser metatarsal heads bilaterally and performed arthrodesis of the first metatarsophalangeal joint on one side and resection on the opposite side. We investigated 26 patients (52 feet) who were followed at least one year. Patients were assessed for clinical score, hallux valgus angle (HVA), angle between first and second metatarsals, and angle between first and fifth metatarsals preoperatively, postoperatively and at final follow-up. We evaluated callosities, claw toes, recurrences, and procedure preferences. Results. The mean follow-up period was 4.1 years. No significant differences between arthrodesis and resection were seen, with the exception of HVA. That was significantly less on arthrodesis side (11.5°) than on resection side (17.0°, p  0.05). Seven callosities on resection side and four on arthrodesis side were observed. On resection side, hallux valgus deformity often recurred (15.3%). Patients expressed a significant preference for arthrodesis over resection (p  0.008). Conclusions. Arthrodesis provides better results for maintaining HVA.

Arthrodesis, Clinical results, Forefoot deformity, Resection, Rheumatoid arthritis

Introduction Most patients with rheumatoid arthritis (RA) develop problems with their feet [1]. Pain is the most common presentation, but foot disease may also cause deformity and walking difficulties. The prevalence of forefoot deformities in adult patients who have chronic rheumatic disease is 80–100% [1–4]. Soft-tissue instability and joint destruction results in hallux valgus, subluxation or dislocation of the lesser toes and displacement of the plantar fat pad with associated metatarsalgia [5,6]. Conservative treatment remains the mainstay of management for RA, using diseasemodifying anti-rheumatic drugs and biologics. Shoe modifications and ambulatory aids are frequently beneficial. Despite such measures, some patients continue to deteriorate and surgical correction may be required. Methods for treatment of the painful, deformed rheumatoid forefoot have included resection of the first metatarsal head [7,8], arthrodesis of the first metatarsophalangeal (MTP) joint [9,10], excision of the base of the proximal phalanx (Keller’s operation) [11,12], and silicone hinge replacement [13,14]. Correspondence to: Tatsuya Koike, Center for Senile Degenerative Disorders, Osaka City University Medical School, 1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan. Tel:  81-6-6646-6010. Fax:  81-66646-6010. E-mail: [email protected]

History Received 20 May 2014 Accepted 17 August 2014 Published online 7 October 2014

However, the ideal surgical treatment for the hallux in the rheumatoid forefoot remains controversial. Several studies have compared patient outcomes between arthrodesis and resection arthroplasty of the first MTP joint. Arthrodesis offers several advantages, including durable deformity correction, relief of pain, and predictable outcomes, compared with resection arthroplasty. Recurrent deformity of both the hallux and lesser toes has been reported when hallux valgus deformity is managed by resection [12,15–18]. This criticism, however, was based on historical observations from previous studies, and only one prospective or randomized study has been performed [19]. That study compared arthrodesis and Mayo resection of the first MTP joint, allocated to two groups. No significant differences were observed between groups. However, the study was limited by low statistical power as a result of the small patient numbers (resection, 16 cases; fusion, 15 cases). We therefore performed a prospective, randomized, internal-controlled clinical study. Our study aimed to compare clinical and radiological results of arthrodesis and resection of the first MTP joint and to determine preferences for surgical procedures performed as simultaneous operations for patients with two painful, deformed rheumatoid forefeet. Arthrodesis was hypothesized to be better than resection in terms of clinical, radiological outcomes and patient preference.

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DOI 10.3109/14397595.2014.956984

Material and methods Patients Between April 2004 and December 2010, a total of 30 patients with two severely painful deformed rheumatoid forefeet were included in our prospective, randomized, internal-controlled clinical study. Procedures were randomly assigned to performed arthrodesis or resection of the first MTP joint in simultaneous operation of individual patients. RA patients were classified according to the 1987 criteria of the America College of Rheumatology [20]. They were allocated to undergo both arthrodesis and resection (one on each foot) at the first MTP joint combined with resection of the metatarsal heads of both lesser toes. We investigated 26 patients (52 feet), all of whom received at least one year of follow-up. The follow-up period for the remaining four patients was less than one year. At the time of operation, mean age was 66.3  6.7 years (range, 50–78 years). Patients were predominantly female (92.3%), mean disease duration was 16.5  7.8 years (range, 6–30 years), and mean Disease Activity Score (DAS) 28-CRP [21] was 4.26  0.95 (range, 2.41–6.97). The mean duration of follow-up was 4.1  2.1 years (range, 1.3–7.8 years). Twenty-five patients (96.2%) had been treated with disease modifying antirheumatic drugs (Methotrexate 76.9%, Salazosulfapyridine 30.8%, Bucilamine 11.5%, and Tacrolimus 7.7%) and seven patients (26.9%) had been treated with biologic agents before surgery. The percentage of steroid use was 53.8% (mean  S.D., 5.6  2.9 mg/day). The study was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry [http://www.umin.ac.jp/ctr/] (UMIN000004646). The study protocol was approved by the Ethics Committee of Osaka City University Medical School (No. 1793) and by the ethics committee of the entry hospital. All patients provided written informed consent prior to enrolment. Surgical procedure All operations were performed under general anesthesia, with the application of tourniquets for bilateral thighs. A plantar transverse incision was made for resection of the second to fifth metatarsal heads. Another incision was made on the medial side of the first MTP joint and performed bunionectomy. After the adductor tendon was released from the proximal phalanx of the first toe, we performed resection of the first metatarsal head and the base of the proximal phalanx of the first toe. The first metatarsal head was excised by 10° of abduction and 20° of dorsiflexion to the first metatarsal bone. On the resection side, a φ1.5-mm Kirschner wire was inserted longitudinally, transfixing the first MTP joint for 3 weeks. This procedure is known as the LeLièvre method [22]. On the arthrodesis side, we used an Acutrak screw (Kobayashi Medical, Osaka, Japan) or Surfplate (Nakashima Medical, Okayama, Japan) to fix the first MTP joint. After confirmed the congruence of bone surface by fluoroscopy, phalanx and metatarsal bone were fixed rigidly by two cross Acutrak screws or one Surfplate. In the case of gap between bones, we performed local bone graft harvested from metatarsal heads. Both sides were allowed weight-bearing on their heels, as tolerated, in functional insoles from postoperative day one. Clinical and radiographic evaluations For clinical assessment, the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale (full marks  100 points) [23] was used preoperatively, postoperatively, and at final follow-up. We asked all patients if they felt more satisfied with results for the right or left side to investigate patient preferences. They could choose from three

candidates: arthrodesis; resection; or no preference. For radiographic assessment, a standing anteroposterior radiograph was taken preoperatively, postoperatively, and at final follow-up to measure the hallux valgus angle (HVA), the angle between the first and second metatarsal (M1M2), and the angle between the first and fifth metatarsal (M1M5). Callosities and recurrence of hallux valgus were evaluated at final follow-up. Statistical analysis All data are presented as mean  standard deviation (SD). AOFAS score, HVA, M1M2, and M1M5 angles preoperatively, postoperatively, and at final follow-up were compared between sides using paired t-tests. AOFAS and content scores between arthrodesis and resection sides were compared using unpaired t-tests. Procedure preferences were assessed using Fisher’s exact probability test. A value of p  0.05 was considered significant. All statistical analyses were performed using StatView 5.0 software package (SAS Institute Japan, Tokyo, Japan).

Results Clinical assessment Postoperatively, mean AOFAS score improved significantly from 30.3  12.1 to 82.1  6.2 and from 30.6  12.1 to 83.0  5.4 on the arthrodesis and resection sides, respectively. At final follow-up, AOFAS score was decreased compared to postoperative score (Table 1). Total AOFAS score tended to be lower on the resection side (74.2  10.3) than on the arthrodesis side (77.9  7.1; p  0.14). Significant improvements in all components of the AOFAS score were seen between preoperative and both postoperative and at final follow-up assessments on both sides. Patients also reported excellent satisfaction with both sides. However, the patient preferences for procedures differed, with 14 patients preferring the arthrodesis side, five patients preferring the resection side, and seven patients expressing no preference. Significant differences were apparent between procedure sides (p  0.008, Fisher’s exact probably test). Seven callosities on the resection side and four callosities on the arthrodesis side were observed at final follow-up. About recurrence of hallux valgus deformity (HVA  20°), resection side had more frequency than arthrodesis side. Four claw toes on the resection side and two claw toes on the arthrodesis side occurred (Table 2). Alignment score was significantly lower on the resection side than on the arthrodesis side (p  0.04) at final follow-up (Table 1). On the arthrodesis side, no complications of pseudarthrosis or nonunion Table 1. Clinical results of arthrodesis and resection side.

AOFAS total score Preoperative Postoperative Final follow-up Pain score Preoperative Postoperative Final follow-up Function score Preoperative Postoperative Final follow-up Alignment score Preoperative Postoperative Final follow-up

Arthrodesis (n  26)

Resection (n  26)

P

30.3  12.1 82.1  6.2 77.9  7.1

30.6  12.1 83.0  5.4 74.2  10.3

0.93 0.58 0.14

6.9  9.7 38.5  3.7 36.9  4.7

6.9  9.7 38.5  3.7 36.2  5.0

– – 0.57

23.1  6.8 28.7  3.7 27.3  3.8

23.1  6.7 29.5  3.5 26.7  4.4

– 0.38 0.54

0.3  1.6 15.0  0.0 13.7  2.8

0.6  2.2 15.0  0.0 11.4  4.7

0.56 – 0.04

AOFAS American Orthopaedic Foot and Ankle Society.

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Table 2. Recurrence of hallux valgus, callosities, and claw toes.

Hallux valgus (HVA  20°), (%) Callosities, (%) Claw toes, (%)

Arthrodesis (n  26) 1 case (3.8%) 4 cases (15.3%) 2 cases (7.7%)

Resection (n  26) 4 cases (15.3%) 7 cases (26.9%) 4 cases (15.3%)

HVA hallux valgus angle.

of the first MTP joint and breakage of the implant were encountered. Deep infection was not observed with either procedure. Although two patients in each procedure developed superficial infection and delayed healing, all patients recovered completely with the use of antibiotic drugs. Radiographic assessment Radiographic results are shown in Figure 1. Postoperatively, HVA was significantly improved compared to preoperative assessment on both arthrodesis and resection sides (arthrodesis: 9.6  4.1°, p  0.05; resection: 9.8  3.2°, p  0.05). M1M2 and M1M5 angles showed the same tendencies, with significantly improved scores compared to postoperative scores and maintenance of those angles at final follow-up with both procedures. No significant differences were apparent between sides, with the exception of

Figure 2. Radiographic changes in HVA. Radiography of the foot of a 65-year-old female patient taken preoperatively (a), postoperatively (b), and at final follow-up (3 years postoperatively) (c). She simultaneously underwent arthrodesis on the left side with a Surfplate and resection on the right side. On both sides, HVA was decreased postoperatively (arthrodesis side: from 45.8° to 11.8°; resection side: from 50.0° to 10.4°). HVA was maintained on the arthrodesis side at final follow-up (12.8°), but was increased on the resection side (18.7°).

Figure 1. Radiographic results obtained preoperatively, postoperatively, and at final follow-up. HVA (a), M1M2 angle (b), and M1M5 angle (c) of the arthrodesis side and resection side. Values are given as mean  SD. *p  0.05 between procedures at final follow-up.

HVA. HVA was significantly higher on the resection side than on the arthrodesis side at final follow-up (p  0.05). On the resection side, HVA was significantly improved postoperatively, but had deteriorated by final follow-up. Conversely, on the arthrodesis side, HVA was significantly improved postoperatively, and was maintained at final follow-up (Figure 2).

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Discussion Hallux valgus, claw toe, and digitus varus minimi are known to be flattening triangle deformities of the rheumatoid forefoot. Complaints from patients suffering these pathologies include bunion pain, metatarsalgia, and callosities of the plantar MTP joint and dorsal proximal interphalangeal joint. Surgeons have reported various surgical procedures with dorsal or plantar incisions, with excision of the metatarsal heads and/or base of the proximal phalanges [11,24–26]. Most attention has been directed at treatment of the first toe, and arthrodesis and resection are the two major surgical options. In the literature, good to excellent success rates for resection vary from 51% to 93% [16,27,28]. Major complaints have been the high recurrence rates of hallux valgus, metatarsalgia, and plantar callosities, up to 53%, 36%, and 61%, respectively [12,15–17]. Controversy remains regarding which of arthrodesis or resection is preferable for treating the first toe. Grondal et al. reported no significant differences in recurrence of the deformity or patient satisfaction between arthrodesis and Mayo resection in a prospective randomized study [19]. On the other hand, Torikai et al. revealed arthrodesis as superior to resection in terms of maintaining HVA, with arthrodesis identified as the most reliable method for treating deformity of the rheumatoid forefoot [18]. That study only compared arthrodesis and resection between individual patients and no investigations have compared these procedures in the same patients after simultaneous operations. The strong point of the present study was thus the comparison of arthrodesis and resection in internal controls. The comparison between right and left toes for different procedures was able to avoid the influence of systemic inflammation of RA. In addition, this method enabled comparison under more consistent conditions. Recurrence of hallux valgus deformity and callosities was affected by not only surgical technique, but also control of disease activity. By performing comparisons in the same patient, we were able to exclude the influence of systemic inflammation and evaluate recurrence rates directly based on surgical technique. We investigated the correlation between change of HVA and change of disease activity by using univariate analysis. The disease activity did not correlate with change of HVA in both sides (resection side; r  0.325, p  0.106, arthrodesis side; r  0.055, p  0.791). In our prospective, randomized, internal-controlled clinical study, clinical assessments showed that patient satisfaction was high and symptoms were significantly improved compared to preoperative conditions on both sides. No significant differences were evident between sides postoperatively or at final follow-up. However, patients tended to prefer arthrodesis over resection. In terms of reasons, we thought that the higher pressure was supported by the fixed first MTP joint and a more favorable pressure distribution on metatarsals II-V was achieved on the arthrodesis side. On radiographic assessment, HVA on the arthrodesis side was maintained at final follow-up. On the other hand, on the resection side, HVA gradually increased at final follow-up compared to that at immediately postoperative assessment. Recurrence of hallux valgus, metatarsalgia, and plantar callosities may thus be prevented on the arthrodesis side compared to the resection side in the mid- or long-term. On the resection side, all five metatarsal heads and part of the proximal phalanges were left excised for a long time postoperatively and the distal of hallux was medially pulled by the first metatarsal bone and soft tissues, because splaying of the foot remained despite the surgery. The flexor and extensor hallucis longus tendons also influenced medialization of the hallux. Meanwhile, on the arthrodesis side, the distal hallux opposed the medialization force and recurrence of hallux valgus was able to be prevented by fusion of the metatarsus and proximal phalanx.

Several disadvantages of arthrodesis have been reported. The operative technique is more demanding. Alignment of the hallux is crucial, but can be difficult to achieve [15,29]. The rate of pseudarthrosis has been reported to vary from 0 to 26% [9,28]. Interphalangeal joint degeneration can develop. In the present study, operation time was longer for arthrodesis than for resection. However, we have encountered no pseudarthrosis of the first MTP joint, breakage of the implant, or development of interphalangeal joint degeneration. Besides arthrodesis and resection, silicone hinge replacement of the first metatarsal joint has been performed, with good clinical results reported in several studies [13,30]. In the future, it will be necessary to consider which of arthrodesis or replacement is better. Recently, it was reported that osteotomy of the first metatarsal was useful procedure for RA patients without sever damage of metatarsal head over short term [31]. This procedure may be suitable for nondestructive metatarsal head under control disease activity. Some limitations to the present study must be considered. First, the patient population was small. This was because obtaining patient consent for carrying out this study with different simultaneous procedures was difficult and prolonged the recruitment process. Second, it was difficult for patients who underwent simultaneous operations to evaluate the function of each foot separately. Although this is a problem when assessing function using AOFAS score after bilateral operations on the feet, we believe that we were able to obtain accurate information by careful assessment. Third, the follow-up period was relatively short, with a mean of only 4.1 years. No significant differences in AOFAS score were seen in the short term. However, we consider that AOFAS score in the midor long-term is likely to be higher with arthrodesis than with resection. In our prospective, randomized, internal-controlled clinical study, arthrodesis of the first MTP joint provided better results in terms of maintenance of the HVA, although no significant difference in AOFAS scores were identified. Patients preferred arthrodesis over resection of the first MTP joint for rheumatoid forefoot deformity. Arthrodesis of the first MTP joint appears to offer a reliable option for the treatment of rheumatoid forefoot deformity.

Conflict of interest Dr. Koike has received research grants and/or speaking fees from Takeda Pharmaceutical, Mitsubishi Tanabe Pharma Corporation, Chugai Pharmaceutical, Eisai, Abbott Japan, Teijin Pharma, Banyu Pharmaceutical and Ono Pharmaceutical. Dr. Nakamura has received research grants and/or speaking fees from Chugai Pharmaceutical, Astellas Pharma, Janssen Pharmaceutica, GlaxoSmithKline, Pfizer, Daiichi Sankyo and Ono Pharmaceutical. All other authors have declared no conflicts of interest.

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Preference of surgical procedure for the forefoot deformity in the rheumatoid arthritis patients--A prospective, randomized, internal controlled study.

The deformed rheumatoid forefoot may be treated with resection of lesser metatarsal heads combined with arthrodesis or resection of the first metatars...
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