518503
research-article2014
FAIXXX10.1177/1071100713518503Foot & Ankle InternationalGiannini et al
Article
Survivorship of Bipolar Fresh Total Osteochondral Ankle Allograft
Foot & Ankle International® 2014, Vol. 35(3) 243–251 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1071100713518503 fai.sagepub.com
Sandro Giannini, MD1, Roberto Buda, MD1, Gherardo Pagliazzi, MD1, Alberto Ruffilli, MD1, Marco Cavallo, MD1, Matteo Baldassarri, MD1, and Francesca Vannini, MD, PhD1
Abstract Background: Severe posttraumatic ankle arthritis poses a reconstructive challenge in the young and active patient. Bipolar fresh total osteochondral allograft (BFTOA) may represent an intriguing alternative to arthrodesis and prosthetic replacement. The purpose of this article was to evaluate the outcomes of BFTOA performed through an anterior approach to the ankle and to investigate the parameters influencing the results. Methods: A total of 26 patients (18 males and 8 females with a mean age of 34.9 ± 7.7 years) underwent BFTOA. The allograft was prepared with the help of specifically designed jigs and the surgery was performed using a direct anterior approach. Patients were evaluated clinically and radiographically at 2, 4, 6, and 12 months after the operation, and at a mean 40.9 ± 14.1 months of follow-up. Radiographic evaluation included the measurement of allograft size matching and alignment. Results: The AOFAS score improved from 26.6 ± 6 preoperatively to 77.8 ± 8.7 after a mean follow-up of 40.9 ± 14.1 months (P < .0005). Six failures occurred. Joint degeneration was classified as 2 in 12 and as 3 in 14 patients. A statistically significant correlation between low degrees of distal tibial slope and better clinical outcomes was observed (P = .049). Conclusion: BFTOA appears to be a viable option to arthrodesis or arthroplasty. Precise allograft sizing, stable fitting, and fixation and delayed weight-bearing were key factors for a successful outcome. In this series the correct alignment of the tibial graft, in terms of slope, was found to play a crucial role in the allograft survivorship. Level of Evidence: Level IV, case series. Keywords: arthritis, biomechanics, gait studies, trauma, outcome studies Severe posttraumatic ankle arthritis poses a reconstructive challenge in the young and active patient. Operative treatment typically relies on arthrodesis or prosthetic arthroplasty.27,28 Arthrodesis is currently considered the gold standard for end-stage arthritis of the ankle joint, but major concerns on functional and psychological limitations, associated with possible arthritis at ipsilateral foot joints, remain.7,10 Major drawbacks of prosthetic replacement are the lack of long-term outcomes and the inevitable loosening of joint arthroplasty in the young and active population.21 Bipolar fresh total osteochondral allograft (BFTOA) transplantation has been shown in a few reports to provide a sort of biological prosthesis progressively integrated by the host and to be an alternative to arthrodesis and prosthetic replacement. The use of frozen allografts in limb salvage surgery for malignant bone tumors, alone or in association with a prosthesis as a modular, versatile, and durable substitution of a resected bone segment, is well documented.8,30 More recently, further research in allograft biology and preservation, followed by the establishment of large institutional bone banks,
has led to an increasing number of fresh allograft transplantations.14,18 To date, the use of fresh osteochondral allografting to replace damaged articular cartilage is well established.2,3,5-7,23,24 BFTOA in the ankle joint is a technically demanding procedure with reported intraoperative and postoperative complications,28 associated with controversies for its indications and outcomes. Different techniques have been reported for BFTOA in the ankle using either an anterior approach, with the help of ankle prosthesis instrumentation,17,19,22 and lateral transmalleolar one.11 The aim of this article was to evaluate the clinical and radiographic outcomes of a series of ankle BFTOA performed through an
1
Istituti Ortopedici Rizzoli, Bologna University, Bologna, Italy
Corresponding Author: Gherardo Pagliazzi, MD, I Clinic, Istituti Ortopedici Rizzoli, Via Giulio Cesare Pupilli 1, Bologna University, 40136 Bologna, Italy. Email: [email protected]
Downloaded from fai.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 18, 2015
244
Foot & Ankle International 35(3)
anterior operative approach and to identify the factors influencing the results.
Methods From June 2007 to April 2010, 26 patients (18 males and 8 females with a mean age of 34.9 ± 7.7 years) underwent BFTOA for end-stage posttraumatic ankle osteoarthritis. Inclusion criteria were patients less than 50 years with unilateral ankle arthritis grade III25 with pain unresponsive to a minimum of 6 months of medical and physical therapy, limiting the activities of daily living. Contraindications for surgery included inflammatory rheumatic disease, infections, reflex sympathetic dystrophy, osteopenia, vascular and neurologic diseases. Lower limb malalignment and chronic instability were addressed operatively before or during the transplantation procedure. Fifteen percutaneous Achilles lengthening for Achilles contracture, 1 tenotomy of the flexor digitorum longus of the first ray, and 1 peroneal tenodesis were performed as associated procedures during allograft transplantation. Patients were evaluated before surgery by means of physical examination, weight-bearing radiographs, and the American Orthopaedic Foot and Ankle Society hindfoot score (AOFAS).20 Plain anteroposterior and lateral weight-bearing radiographs and a CT scan of the affected ankle were taken. The size of the patients’ ankle was digitally measured on the CT scans. Candidates were then placed on a waiting list until an appropriate sized donor become available. Fresh anatomically appropriate tissue was obtained from healthy donors who met the criteria of the Bone Bank program for tissue donation. Allografts were harvested within 24 hours from death and were transplanted fresh within a mean of 13.8 ± 1.9 days from procurement. Harvesting of the ankle from the donor involved excision of the entire joint with an intact capsule and synovial membrane. Grafts were then immersed in a solution containing L-glutamine, NaHCO3 and antibiotics. These harvested tissues were stored at 4°C until transplantation. The size of the donor tibia and talus was measured using CT scans and an appropriate candidate was selected based on the ankle size. Donors’ and recipients’ ABO blood group and Rh blood group were recorded, but no matching was made according to these parameters between patients and donors. The study was approved by the Ethics Committee of the authors’ institution, and informed consent was obtained from all patients after extensive discussions about the various risks, benefits, and alternatives to fresh osteochondral allografting
Operative Technique Operative treatment was performed in 2 steps, one for the graft preparation and the other for surgery on the recipient.
Figure 1. Operative field showing the ankle joint exposed through an anterior direct approach.
On a separate table, the harvested ankle had all soft tissues removed. Care was taken not to damage the cartilage surface. The fibula was removed and the medial malleolus surface was cut with the help of a specifically designed jig held in place by a K wire. Then, the tibial surface was first prepared by using two 2 mm K-wires to define the planes of cut. The cut was performed at a proper level to obtain a 1 cm thick osteochondral surface. The talar surface was then prepared with the same method, taking care to obtain a 1 cm thick talar dome surface (in its central portion) as well. The articular surfaces obtained were placed in saline during the host implant site preparation. The patient was placed supine under general or spinal anesthesia with a thigh tourniquet. The ankle joint was approached through an anterior midline incision between the extensor hallucis longus and tibialis anterior tendons. No osteotomies of the medial malleolus, fibula, or tibialis anterior plafond were employed. The neurovascular bundle was retracted laterally. An extensive synovectomy was performed to obtain a wide exposure of the ankle joint (Figure 1). Anterior osteophytes and fibrous tissues were removed. The medial malleolar surface was prepared with the same specifically designed jig previously used for the cut of the donor surfaces (Figure 2). Then, two 2 mm K-wires were
Downloaded from fai.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 18, 2015
245
Giannini et al
Figure 2. Operative field showing the positioning of the designed jig for the medial malleolus surface cutting.
positioned and checked by fluoroscopy both on the tibia and the talus at the same distance from the joint line used in preparing the graft and both the distal tibial and talar surfaces were cut and removed. To avoid thermal damage, frequent irrigations of the operative field were performed during surfaces preparation. Any surface irregularities in the prepared site were checked and removed. Allograft surfaces were positioned in the host ankle with temporary fixation and the congruency and fit of the implant was checked under fluoroscopy. If a gap between the host and the implant graft was present, it was filled with cancellous bone harvested from the osteochondral surfaces removed from the patient. Tibial components were fixed by 2 standard titanium screws, while either twist-off screws (De Puy Orthopaedics Inc, Warsaw, IN, USA) or Herbert screws were used for talar fixation (Zimmer Inc, Warsaw, IN, USA; Figure 3). The ankle was tested for range of motion in dorsiflexion and plantarflexion and for stability. The tourniquet was deflated and a hemostasis was performed. Finally, the ankle joint capsule was closed over the allograft after implantation, followed by skin closure.
Postoperative Treatment Following surgery, a plaster cast was applied for 3 weeks. After cast removal, patients were encouraged to actively and passively move their ankle. The range of motion was then gradually increased during this phase according to pain. Patients were kept non-weight-bearing on the affected ankle for 4 months postoperatively. Partial weight-bearing (30 kg) was permitted from 4 months after surgery if radiological signs of healing were visible. Six months after surgery complete weight-bearing was advised.
Figure 3. Operative field showing allograft surfaces positioned in the host site and fixed with 2 standard titanium screws for the tibial surface, and with 2 Herbert screws for the talar surface.
One year after the transplantation procedure, 23 patients underwent hardware removal associated with joint
Downloaded from fai.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 18, 2015
246
Foot & Ankle International 35(3)
arthrolysis. During hardware removal, 1 patient underwent a calcaneal osteotomy for cavus foot correction. Two other patients required an additional procedure: a tenotomy of the first flexor digitorum longus, and a tenotomy of the I, II, III, IV flexor digitorum longus associated with revision of a midtarsal joint arthrodesis, respectively, 11 and 60 months after the transplantation procedure.
Postoperative Patient Evaluation Patients were evaluated clinically and radiographically at 2, 4, 6, and 12 months after operation, and at a final follow-up of 40.9 ± 14.1 months. Patient outcomes were evaluated with the AOFAS score.20 Results were rated as follows: excellent (90-100), good (70-89), fair (50-69), poor (
research-article2014
FAIXXX10.1177/1071100713518503Foot & Ankle InternationalGiannini et al
Article
Survivorship of Bipolar Fresh Total Osteochondral Ankle Allograft
Foot & Ankle International® 2014, Vol. 35(3) 243–251 © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1071100713518503 fai.sagepub.com
Sandro Giannini, MD1, Roberto Buda, MD1, Gherardo Pagliazzi, MD1, Alberto Ruffilli, MD1, Marco Cavallo, MD1, Matteo Baldassarri, MD1, and Francesca Vannini, MD, PhD1
Abstract Background: Severe posttraumatic ankle arthritis poses a reconstructive challenge in the young and active patient. Bipolar fresh total osteochondral allograft (BFTOA) may represent an intriguing alternative to arthrodesis and prosthetic replacement. The purpose of this article was to evaluate the outcomes of BFTOA performed through an anterior approach to the ankle and to investigate the parameters influencing the results. Methods: A total of 26 patients (18 males and 8 females with a mean age of 34.9 ± 7.7 years) underwent BFTOA. The allograft was prepared with the help of specifically designed jigs and the surgery was performed using a direct anterior approach. Patients were evaluated clinically and radiographically at 2, 4, 6, and 12 months after the operation, and at a mean 40.9 ± 14.1 months of follow-up. Radiographic evaluation included the measurement of allograft size matching and alignment. Results: The AOFAS score improved from 26.6 ± 6 preoperatively to 77.8 ± 8.7 after a mean follow-up of 40.9 ± 14.1 months (P < .0005). Six failures occurred. Joint degeneration was classified as 2 in 12 and as 3 in 14 patients. A statistically significant correlation between low degrees of distal tibial slope and better clinical outcomes was observed (P = .049). Conclusion: BFTOA appears to be a viable option to arthrodesis or arthroplasty. Precise allograft sizing, stable fitting, and fixation and delayed weight-bearing were key factors for a successful outcome. In this series the correct alignment of the tibial graft, in terms of slope, was found to play a crucial role in the allograft survivorship. Level of Evidence: Level IV, case series. Keywords: arthritis, biomechanics, gait studies, trauma, outcome studies Severe posttraumatic ankle arthritis poses a reconstructive challenge in the young and active patient. Operative treatment typically relies on arthrodesis or prosthetic arthroplasty.27,28 Arthrodesis is currently considered the gold standard for end-stage arthritis of the ankle joint, but major concerns on functional and psychological limitations, associated with possible arthritis at ipsilateral foot joints, remain.7,10 Major drawbacks of prosthetic replacement are the lack of long-term outcomes and the inevitable loosening of joint arthroplasty in the young and active population.21 Bipolar fresh total osteochondral allograft (BFTOA) transplantation has been shown in a few reports to provide a sort of biological prosthesis progressively integrated by the host and to be an alternative to arthrodesis and prosthetic replacement. The use of frozen allografts in limb salvage surgery for malignant bone tumors, alone or in association with a prosthesis as a modular, versatile, and durable substitution of a resected bone segment, is well documented.8,30 More recently, further research in allograft biology and preservation, followed by the establishment of large institutional bone banks,
has led to an increasing number of fresh allograft transplantations.14,18 To date, the use of fresh osteochondral allografting to replace damaged articular cartilage is well established.2,3,5-7,23,24 BFTOA in the ankle joint is a technically demanding procedure with reported intraoperative and postoperative complications,28 associated with controversies for its indications and outcomes. Different techniques have been reported for BFTOA in the ankle using either an anterior approach, with the help of ankle prosthesis instrumentation,17,19,22 and lateral transmalleolar one.11 The aim of this article was to evaluate the clinical and radiographic outcomes of a series of ankle BFTOA performed through an
1
Istituti Ortopedici Rizzoli, Bologna University, Bologna, Italy
Corresponding Author: Gherardo Pagliazzi, MD, I Clinic, Istituti Ortopedici Rizzoli, Via Giulio Cesare Pupilli 1, Bologna University, 40136 Bologna, Italy. Email: [email protected]
Downloaded from fai.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 18, 2015
244
Foot & Ankle International 35(3)
anterior operative approach and to identify the factors influencing the results.
Methods From June 2007 to April 2010, 26 patients (18 males and 8 females with a mean age of 34.9 ± 7.7 years) underwent BFTOA for end-stage posttraumatic ankle osteoarthritis. Inclusion criteria were patients less than 50 years with unilateral ankle arthritis grade III25 with pain unresponsive to a minimum of 6 months of medical and physical therapy, limiting the activities of daily living. Contraindications for surgery included inflammatory rheumatic disease, infections, reflex sympathetic dystrophy, osteopenia, vascular and neurologic diseases. Lower limb malalignment and chronic instability were addressed operatively before or during the transplantation procedure. Fifteen percutaneous Achilles lengthening for Achilles contracture, 1 tenotomy of the flexor digitorum longus of the first ray, and 1 peroneal tenodesis were performed as associated procedures during allograft transplantation. Patients were evaluated before surgery by means of physical examination, weight-bearing radiographs, and the American Orthopaedic Foot and Ankle Society hindfoot score (AOFAS).20 Plain anteroposterior and lateral weight-bearing radiographs and a CT scan of the affected ankle were taken. The size of the patients’ ankle was digitally measured on the CT scans. Candidates were then placed on a waiting list until an appropriate sized donor become available. Fresh anatomically appropriate tissue was obtained from healthy donors who met the criteria of the Bone Bank program for tissue donation. Allografts were harvested within 24 hours from death and were transplanted fresh within a mean of 13.8 ± 1.9 days from procurement. Harvesting of the ankle from the donor involved excision of the entire joint with an intact capsule and synovial membrane. Grafts were then immersed in a solution containing L-glutamine, NaHCO3 and antibiotics. These harvested tissues were stored at 4°C until transplantation. The size of the donor tibia and talus was measured using CT scans and an appropriate candidate was selected based on the ankle size. Donors’ and recipients’ ABO blood group and Rh blood group were recorded, but no matching was made according to these parameters between patients and donors. The study was approved by the Ethics Committee of the authors’ institution, and informed consent was obtained from all patients after extensive discussions about the various risks, benefits, and alternatives to fresh osteochondral allografting
Operative Technique Operative treatment was performed in 2 steps, one for the graft preparation and the other for surgery on the recipient.
Figure 1. Operative field showing the ankle joint exposed through an anterior direct approach.
On a separate table, the harvested ankle had all soft tissues removed. Care was taken not to damage the cartilage surface. The fibula was removed and the medial malleolus surface was cut with the help of a specifically designed jig held in place by a K wire. Then, the tibial surface was first prepared by using two 2 mm K-wires to define the planes of cut. The cut was performed at a proper level to obtain a 1 cm thick osteochondral surface. The talar surface was then prepared with the same method, taking care to obtain a 1 cm thick talar dome surface (in its central portion) as well. The articular surfaces obtained were placed in saline during the host implant site preparation. The patient was placed supine under general or spinal anesthesia with a thigh tourniquet. The ankle joint was approached through an anterior midline incision between the extensor hallucis longus and tibialis anterior tendons. No osteotomies of the medial malleolus, fibula, or tibialis anterior plafond were employed. The neurovascular bundle was retracted laterally. An extensive synovectomy was performed to obtain a wide exposure of the ankle joint (Figure 1). Anterior osteophytes and fibrous tissues were removed. The medial malleolar surface was prepared with the same specifically designed jig previously used for the cut of the donor surfaces (Figure 2). Then, two 2 mm K-wires were
Downloaded from fai.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 18, 2015
245
Giannini et al
Figure 2. Operative field showing the positioning of the designed jig for the medial malleolus surface cutting.
positioned and checked by fluoroscopy both on the tibia and the talus at the same distance from the joint line used in preparing the graft and both the distal tibial and talar surfaces were cut and removed. To avoid thermal damage, frequent irrigations of the operative field were performed during surfaces preparation. Any surface irregularities in the prepared site were checked and removed. Allograft surfaces were positioned in the host ankle with temporary fixation and the congruency and fit of the implant was checked under fluoroscopy. If a gap between the host and the implant graft was present, it was filled with cancellous bone harvested from the osteochondral surfaces removed from the patient. Tibial components were fixed by 2 standard titanium screws, while either twist-off screws (De Puy Orthopaedics Inc, Warsaw, IN, USA) or Herbert screws were used for talar fixation (Zimmer Inc, Warsaw, IN, USA; Figure 3). The ankle was tested for range of motion in dorsiflexion and plantarflexion and for stability. The tourniquet was deflated and a hemostasis was performed. Finally, the ankle joint capsule was closed over the allograft after implantation, followed by skin closure.
Postoperative Treatment Following surgery, a plaster cast was applied for 3 weeks. After cast removal, patients were encouraged to actively and passively move their ankle. The range of motion was then gradually increased during this phase according to pain. Patients were kept non-weight-bearing on the affected ankle for 4 months postoperatively. Partial weight-bearing (30 kg) was permitted from 4 months after surgery if radiological signs of healing were visible. Six months after surgery complete weight-bearing was advised.
Figure 3. Operative field showing allograft surfaces positioned in the host site and fixed with 2 standard titanium screws for the tibial surface, and with 2 Herbert screws for the talar surface.
One year after the transplantation procedure, 23 patients underwent hardware removal associated with joint
Downloaded from fai.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 18, 2015
246
Foot & Ankle International 35(3)
arthrolysis. During hardware removal, 1 patient underwent a calcaneal osteotomy for cavus foot correction. Two other patients required an additional procedure: a tenotomy of the first flexor digitorum longus, and a tenotomy of the I, II, III, IV flexor digitorum longus associated with revision of a midtarsal joint arthrodesis, respectively, 11 and 60 months after the transplantation procedure.
Postoperative Patient Evaluation Patients were evaluated clinically and radiographically at 2, 4, 6, and 12 months after operation, and at a final follow-up of 40.9 ± 14.1 months. Patient outcomes were evaluated with the AOFAS score.20 Results were rated as follows: excellent (90-100), good (70-89), fair (50-69), poor (
