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

N/ACompletedNCT03719417

University of Missouri-Columbia14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis Post-traumatic Osteoarthritis

Interventions

Unicompartmental Biologic ArthroplastyPROCEDURE

Unicompartmental Biologic Arthroplasty surgery.

Extensive Biologic ArthroplastyPROCEDURE

Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Missouri Orthopaedic Institute

Columbia, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: 12 Months

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 12 Months

Data from ClinicalTrials.gov

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