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

University of Missouri (MU)

Status: Completed

Conditions: Post-traumatic Osteoarthritis; Knee Osteoarthritis

Treatments: Procedure: Extensive Biologic Arthroplasty; Procedure: Unicompartmental Biologic Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03719417

2011153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Unicompartmental Biologic Arthroplasty

Active Comparator group

Description:

Subject will be receiving a unicompartmental biologic arthroplasty only

Treatment:

Procedure: Unicompartmental Biologic Arthroplasty

Extensive Biologic Arthroplasty

Active Comparator group

Description:

Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently.

Treatment:

Procedure: Extensive Biologic Arthroplasty