Indications for Osteochondral Allograft Transplantation

NCT03711747 | Completed

• 1 other identifier: 2011144
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Traumatic Osteoarthritis of Ankle; Ankle Osteoarthritis; Ankle Injuries

Keywords

Ankle; Ankle Pain; Joint Pain; Ankle Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) score

  Pain assessment which measures what a patient rates their pain between 0 and 10, with 0 being no pain, and 10 being the most pain

  12 Months

Secondary Outcomes (2)

• American Orthopaedic Foot and Ankle Society (AOFAS) score

  12 Months

• PROMIS - Physical Function and Mobility

  12 Months

Study Arms (1)

Post-traumatic Ankle OA

Post-traumatic ankle OA and requiring osteochondral allograft to tibia and/or talus in ankle

Procedure: Osteochondral allograft ankle

Interventions

Osteochondral allograft ankle PROCEDURE

Open osteochondral allograft to replace the cartilage that is grade four on the tibia and/or talus

Post-traumatic Ankle OA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• i. Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical exam, diagnostic imaging, and/or arthroscopy by the attending surgeon ii. Between the age of 18-55

You may not qualify if:

• i. Acute injury to any other part of the affected lower extremity ii. Inability to comply with protocol iii. BMI greater than 40 iv. The subject is either pregnant or a prisoner v. Currently involved in worker's compensation case at the time of enrollment

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Orthopaedic Institute

Columbia, Missouri, 65202, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Arthralgia

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James Stannard, MD

  University of Missouri, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Orthopedic Surgery

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: January 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

US (1)