A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 8/29/2018 |
| Start Date: | December 30, 2016 |
| End Date: | April 30, 2019 |
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.
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.
Inclusion Criteria:
1. Patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral
condyle arthroplasty
2. The subject is able and willing to consent to participate in the study
Exclusion Criteria:
1. Acute injury to any other part of the affected lower extremity
2. The subject is unwilling, or unable to consent due to psychiatric condition or legal
incompetence
3. BMI > 40
4. Age > 50 at the time of enrollment
5. The subject is either pregnant, or a prisoner
6. Currently involved in a workers' compensation case at the time of enrollment
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