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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Post-traumatic Osteoarthritis
• Intervention / Treatment: Procedure: Unicompartmental Biologic Arthroplasty; Procedure: Extensive Biologic Arthroplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65202
      • Missouri Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unicompartmental Biologic Arthroplasty; Subject will be receiving a unicompartmental biologic arthroplasty only	Procedure: Unicompartmental Biologic Arthroplasty; Unicompartmental Biologic Arthroplasty surgery.
Active Comparator: Extensive Biologic Arthroplasty; Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently.	Procedure: Extensive Biologic Arthroplasty; Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	12 Months

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: James Stannard, MD, University of Missouri, Department of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Knee Pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2011153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No