A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis
1 other identifier
interventional
14
1 country
1
Brief Summary
Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable knee-osteoarthritis
Started Dec 2018
Longer than P75 for not_applicable knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedStudy Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedNovember 2, 2022
October 1, 2022
3.5 years
October 23, 2018
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS Pain Score (Visual Analog Scale)
This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain
12 Months
Secondary Outcomes (3)
International Knee Documentation Committee Score (IKDC)
12 Months
Single Assessment Numeric Evaluation (SANE) score
12 Months
PROMIS Mobility
12 Months
Study Arms (2)
Unicompartmental Biologic Arthroplasty
ACTIVE COMPARATORSubject will be receiving a unicompartmental biologic arthroplasty only
Extensive Biologic Arthroplasty
ACTIVE COMPARATORSubject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently.
Interventions
Unicompartmental Biologic Arthroplasty surgery.
Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently
Eligibility Criteria
You may qualify if:
- Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint (unicompartmental) or unicompartmental and other femoral condyle, tibial plateau, trochlea and/or patella.
- Between the age of 18-55
You may not qualify if:
- Acute injury to any other part of the affected lower extremity
- Inability to comply with protocol
- BMI greater than 40
- The subject is either pregnant or a prisoner
- Currently involved in worker's compensation case at the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Missouri Orthopaedic Institute
Columbia, Missouri, 65202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Stannard, MD
University of Missouri, Department of Orthopaedic Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Orthopedic Surgery
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 25, 2018
Study Start
December 1, 2018
Primary Completion
June 1, 2022
Study Completion
October 31, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share