Foot and Ankle Bone Healing with a Novel Bone Allograft

DB Kay, MD, Crystal Clinic Inc., Dept. Orthopedic Surgery and Akron General Hospital, Akron, OH
M Herceg, MD, Dept. Orthopedic Surgery, Akron General Hospital, Akron, OH

Abstract

Introduction

The purpose of this study was to examine ankle and bone healing rates using an osteoconductive/inductive bone allograft material. We hypothesized that ankle and bone healing would be equal to that reported in the literature for traditional autograft application and that patient satisfaction would be high due to elimination of graft donor site morbidity.

Materials and Methods

71 consecutive patients for ankle and bone repair were recruited as subjects. Patients were assigned to deformity (n=34), revision (n=15), or bone trauma (n=22) defect groups. One surgeon completed all surgeries. Opteform® (Exactech Inc., Gainesville, FL) was used as the allograft material. The allograft contained both demineralized bone matrix and cortical-cancellous bone in a biologically inert carrier. Patients were followed clinically and radiographically until either healing or an independent reviewer declared failure. Total healing time was based on both clinical (weight bearing without pain) and x-ray (radiographical healing) examinations. Patient satisfaction was queried at the time of study completion. Complications were tracked.

Results

97.2 percent of all patients experienced healing. 97.0 percent of patients in the “deformity” group experienced healing, 93.3 percent of patients in the “revision” group experienced healing, and 100 percent of patients in the “trauma” group experienced healing. Compared to historical data, Opteform  group healing percentages were similar.  However, donor site morbidity was eliminated. Mean ± SE healing time was 68.41 ±  7.7 (Radiologic) and 64.4 ± 6.7 (Clinical) days for the deformity group.  Average healing time was 74.2 ± 10.0 (Radiologic) and 84.0 ± 12.1 (Clinical) days for the revision group.  Average healing time was 70.4 ± 7.0 (Radiologic) and 76.1 ± 7.0 (Clinical) days for the trauma group. Patient satisfaction following surgery was 97.0 percent for the deformity group, 93.3 percent for the revision group, and 100 percent for the trauma group. The incidence of complications was 1.4 percent.

Conclusion

These results show that bone healing occurred at a high rate for all patient groups. Percentages of healing were comparable to historical data for autograft material. Opteform appears to be an effective bone graft material with no incidence of donor site morbidity.

Introduction

Bone grafting is a common necessity for many procedures of the foot and ankle. Further, there continues to be debate regarding the use of either autograft or allograft bone. While autograft has been the long-time gold standard, use of allograft has the inherent advantages of no donor site morbidity and shorter operative time.

With these obvious advantages, we have sought an effective allograft material for use in surgery of the foot and ankle. Opteform^® was chosen for its osteoinductive and osteoconductive properties as well as its structural  integrity. Our goal was to evaluate the effectiveness of Opteform with regard to healing rates and patient satisfaction in common procedures of the foot and ankle.

We have prospectively evaluated 71 consecutive patients that required bone grafting procedures. The senior author was the sole surgeon and each patient received Opteform allograft at the time of surgical intervention. Patients were grouped into degenerative/deformity, revision, and trauma classifications.

Patients were followed both clinically and radiographically until either complete healing or failure was declared. The results of our study were compared to historical controls as reported in the literature for analogous procedures performed with autograft bone grafting.

Methods

• 71 consecutive patients for ankle and bone repair assigned to one of three groups.
  Study entry criteria: foot/ankle procedure, patient requiring bonegraft, follow-up to healingt or failure, adequate radiographs and single surgeon for surgeries.
• Deformity group (n=34) presented with either: DJD/osttraumatic arthritis, posterior tibial tendon dysfunction, cavovarus/ux valgus, charcot arthropathy, rheumatoid arthritis, or tarsal coalition.
• Trauma group (n=22) presented with either: calcaneous fracture, lisfranc fracture-dislocation, or neuropathic fracture-dislocation.
• Revision group (n=15) presented with either: nonunion ankle, nonunion calcaneus, nonunion midfoot, nonunion 1^st MTP, nonunion ankle fusion, or pseudarthrosis nav-cun joint.
• Opteform allograft material consists of demineralized bonematrix, cortical-cancellous bone chips, and inert thermoplastic gel carrier.
• Patients followed clinically and radiographically (Nigro and Grace 1996) at regular intervals (six weeks, three months, six months, and any visit for complications).
• Independent reviewer declared procedure success or failure.
• Total healing time based on clinical (weight bearing without pain) and results from the x-ray (radiologically healed).
• Patient satisfaction (yes or no response) queried at study completion.

Results

• Student t-test for within group comparison and P<0.05 considered significant.
• P=NS, when comparing x-ray and clinical healing times within groups.

Discussion/Conclusion

• Healing/fusion rates compared to autograft material was similar (Monroe et al. 1999) (93 percent), (Flemister et al. 2000) (96 percent) or better than reported in the literature (Easley et al. 2000) (84 percent), (Chou et al. 2000) (86 percent), (Mann and Rongstad 1998)(88 percent).
• No donor site morbidity with a very low incidence of complications (1.4 percent).
  
• High rate of patient satisfaction in all 3 groups (97 percent, 100 percent, 93.3 percent).
  
• We conclude that ankle/foot patients treated with novel bone allograft (Opteform) have healing rates comparable or better than published historical data. 
  
• Additional work is warranted to gauge long term success.

References

Easley ME, Trnka HJ, Schon LC, Myerson MS. Isolated subtalar arthrodesis, J Bone Joint Surg Am  82(5):613-24, 2000.

Flemister AS Jr, Infante AF, Sanders RW, Walling AK. Subtalar arthrodesis for complications of intra-articular calcaneal fractures, Foot Ankle Int 21(5):392-399, 2000.

Chou LB, Mann RA, Yaszay B, Graves SC. Tibiotalocalcaneal arthrodesis, Foot Ankle Int 21(10):804-8, 2000.

Mann RA, Rongstad KM. Arthrodesis of the ankle: a critical analysis, Foot Ankle Int 19(1):3-9, 1998.

Monroe MT, Beals TC, Manoli A. Clinical outcome of arthrodesis of the ankle using rigid internal fixation with cancellous screws, Foot Ankle Int 20(4):227-231, 1999.

Nigro N, Grace D. Radiographic evaluation of bone grafts, J Foot Ankle Surg 35(5):378-385, 1996.

Production of this poster sponsored by:
Exactech, Inc., General Research Fund