A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 10/31/2018 |
| Start Date: | December 1, 2018 |
| End Date: | January 1, 2020 |
| Contact: | Kylee Rucinski |
| Email: | rucinskik@health.missouri.edu |
| Phone: | 573-884-6216 |
A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
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.
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.
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.
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.
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
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