Indications for Osteochondral Allograft Transplantation
Condition: Post-Traumatic Osteoarthritis of Ankle; Ankle Osteoarthritis; Ankle Injuries
MeSH terms: Osteoarthritis; Ankle Injuries
Study type: Observational

Summary: 
      With IRB approval, a prospective single-cohort clinical trial will be performed to assess
      safety and efficacy of total biologic arthroplasty of the ankle. With informed consent,
      patients (n=10) who require tibio-talar arthroplasty based on physical examination and
      diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes
      in the articular cartilage of the tibial plafond and/or talar dome as determined by physical
      examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion
      criteria include acute injury to any other part of the affected lower extremity or inability
      to comply with the protocol.

      After enrollment, patients will undergo standard ankle radiography and complete assessments
      (described below). Size-matched (standard clinical methodology) MOPSTM allografts
      (Musculoskeletal Transplant Foundation, Edison, NJ) from the same donor will be obtained to
      treat the entire tibiotalar joint. The affected joint will be treated with OCA transplants
      using our current technique and instrumentation. Osteochondral grafts including MOPSTM OCAs
      are regulated under U.S. Food and Drug Administration (FDA) section 361 of the Public Health
      Service Act and 21 Code of Federal Regulation 1271 that defines human cells, tissues or
      cellular or tissue based products (HCT/P).

      Patients will follow a managed post-operative rehabilitation protocol that is standard for
      those that have had an osteochondral allograft to their ankle.

      Range of motion and patient-reported outcome measures (PROMs) including VAS pain score,
      AOFAS, and PROMIS Mobility as well as complete radiographs (XR) of the affected ankle will be
      obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to
      evaluate healing, function and evidence for arthrosis. MRIs for cartilage composition (12
      months after surgery, and serum and urine biomarkers for treatment monitoring (preop, 6 and
      12 months after surgery) will be performed. We will document all adverse events and
      complications, including joint or incision infection, graft failure, hardware failure, and
      arthrofibrosis. Patients with a VAS pain score >5 beyond 3 months postoperatively or clinical
      or diagnostic imaging evidence for nonunion or graft collapse will undergo MRI of the ankle
      to determine the appropriate clinical course of action. OCA survival will be determined based
      on maintenance of acceptable levels of pain (<2 VAS) and function and/or need for revision
      surgery or total ankle arthroplasty, fusion, or amputation.
    


Intervention name(s): Osteochondral allograft ankle
Intervention type(s): Procedure
Intervention description(s): Open osteochondral allograft to replace the cartilage that is grade four on the tibia and/or talus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        With informed consent, patients (n=10) who require tibio-talar arthroplasty based on
        physical examination and diagnostic imaging will be enrolled. Primary criteria for
        inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or
        talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by
        the attending surgeon. Exclusion criteria include acute injury to any other part of the
        affected lower extremity or inability to comply with the protocol.
      
Keywords: Ankle; Ankle Pain; Joint Pain; Ankle Osteoarthritis