Loading search results
Sponsor study identifier
observational
10
1 country
1
Study Start
December 30, 2016
Actual (reported)Primary Completion
July 2019
Actual (reported)Study Completion
July 2019
Actual (reported)With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint as determined by physical examination, diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV changes in any other compartment of the knee, acute injury to any other part of the affected lower extremity, or inability to comply with the protocol. After enrollment, patients will undergo standardized knee radiography, and complete assessments (described below). Size-matched (standard clinical methodology) proximal tibia with meniscus and distal femur allografts from the same donor will be obtained from a tissue bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS technology. The medial or lateral femoral condyle will be replaced using our novel instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed and used to replace the entire medial or lateral tibial condyle while sparing the attachments of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated using commercial available implants used for bone fixation. In the event that the meniscus has been detached from the tibial plateau during graft harvest, the periphery of the meniscus will be sutured to the capsule following standard meniscus transplant procedure. Patients will undergo controlled post-operative rehabilitation according to standard protocols for osteochondral with concurrent meniscus allografts. Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected knee 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2016
Actual (reported)August 18, 2017
Actual (reported)August 22, 2017
Actual (reported)July 2019
Actual (reported)July 2019
Actual (reported)January 26, 2021
Actual (reported)Visual Analogue Scale Pain Score
patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain
12 months
Tegner Activity Level Scale
12 months
International Knee Documentation Committee (IKDC) Total Score
12 months
PROMIS - Physical Function and Mobility
12 months
post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Missouri Orthopaedic Institute
Columbia, Missouri, 65212, United States
1 Patient was lost to follow-up after their 6 week follow-up.
James Stannard, MD
University of Missouri, Department of Orthopaedic Surgery
10 participants (actual enrollment reported by the registry).
First Submitted
August 18, 2017
First Posted
August 22, 2017
Study Start
December 30, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
July 2019
Actual (reported)Study Completion
July 2019
Actual (reported)Last Updated
January 26, 2021
Results First Posted
January 26, 2021
Record last verified: 2021-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: