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NCT03711747 · ClinicalTrials.gov registry record
Indications for Osteochondral Allograft Transplantation
A clinical trial of Ankle Injuries and Post-Traumatic Osteoarthritis of Ankle, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT03711747 is a study of Ankle Injuries and Post-Traumatic Osteoarthritis of Ankle that has completed, run by University of Missouri-Columbia. The registered enrollment target is 10 participants, below the 107-participant average among 3 other Ankle Injuries trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03711747, a study of Ankle Injuries and Post-Traumatic Osteoarthritis of Ankle, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 d
Conditions Studied
Interventions
- PROCEDURE Osteochondral allograft ankle
Study Locations (1)
Missouri
- Missouri Orthopaedic Institute - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2022-10-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03711747
The ClinicalTrials.gov registry entry for NCT03711747 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 107-participant average among 3 other Ankle Injuries trials with a reported enrollment target (91% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Ankle Injuries appearing as the primary indexed condition, and to 1 intervention - of which Osteochondral allograft ankle is the first listed.
NCT03711747 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03711747 about?
NCT03711747 is a clinical study titled "Indications for Osteochondral Allograft Transplantation". 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...
What is the current status of trial NCT03711747?
This trial is currently completed. The enrollment target is 10 participants. The study started on 2019-01-01. Estimated completion is 2022-10-01.
What conditions does trial NCT03711747 study?
This clinical trial studies the following conditions: Ankle Injuries, Post-Traumatic Osteoarthritis of Ankle, Ankle Osteoarthritis.
What interventions are being tested in trial NCT03711747?
The interventions under investigation include: Osteochondral allograft ankle (PROCEDURE).
Who is sponsoring clinical trial NCT03711747?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03711747 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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