Indications for Osteochondral Allograft Transplantation by Evaluating Safety and Efficacy of Total Biologic Total Joint Replacement of Ankle Post-traumatic Osteoarthritis (PTOA)

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.