A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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With IRB approval, patients 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. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.

Official Title
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A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)

Conditions
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Knee Osteoarthritis, Post-traumatic Osteoarthritis

Intervention / Treatment
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* Procedure: Unicompartmental Biologic Arthroplasty
* Procedure: Extensive Biologic Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unicompartmental Biologic Arthroplasty<br>Subject will be receiving a unicompartmental biologic arthroplasty only | Procedure: Unicompartmental Biologic Arthroplasty<br>* Unicompartmental Biologic Arthroplasty surgery.<br>|
| Active Comparator: Extensive Biologic Arthroplasty<br>Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently. | Procedure: Extensive Biologic Arthroplasty<br>* Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee Score (IKDC) | This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function score. | 12 Months | 
| Single Assessment Numeric Evaluation (SANE) score | This score looks at what the patient rates their knee with 100% being normal, and 0% being as far from normal as possible | 12 Months | 
| PROMIS Mobility | This looks at mobility and function on a scale of 14.1 to 61.7 with higher scores equaling higher mobility | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Pain