Knee Osteoarthritis, Post-traumatic Osteoarthritis
Conditions
Keywords
Knee Pain
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.
Detailed description
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.
Interventions
PROCEDUREExtensive Biologic Arthroplasty
Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently
PROCEDUREUnicompartmental Biologic Arthroplasty
Unicompartmental Biologic Arthroplasty surgery.
Sponsors
University of Missouri-Columbia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain Score (Visual Analog Scale) | 12 Months | This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Knee Documentation Committee Score (IKDC) | 12 Months | This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function score. |
| Single Assessment Numeric Evaluation (SANE) score | 12 Months | This score looks at what the patient rates their knee with 100% being normal, and 0% being as far from normal as possible |
| PROMIS Mobility | 12 Months | This looks at mobility and function on a scale of 14.1 to 61.7 with higher scores equaling higher mobility |
Countries
United States
Outcome results
None listed