Clinical trial NCT03719417: A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis
Official title: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Post-traumatic Osteoarthritis
Keywords: Knee Pain
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS Pain Score (Visual Analog Scale)
timeFrame: 12 Months
Secondary outcomes:
measure: International Knee Documentation Committee Score (IKDC)
timeFrame: 12 Months
measure: Single Assessment Numeric Evaluation (SANE) score
timeFrame: 12 Months
measure: PROMIS Mobility
timeFrame: 12 Months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: University of Missouri, Department of Orthopaedic Surgery
name: James Stannard, MD
role: PRINCIPAL_INVESTIGATOR
References: