A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis

With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint as determined by physical examination, diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV changes in any other compartment of the knee, acute injury to any other part of the affected lower extremity, or inability to comply with the protocol.

After enrollment, patients will undergo standardized knee radiography, and complete assessments (described below). Size-matched (standard clinical methodology) proximal tibia with meniscus and distal femur allografts from the same donor will be obtained from a tissue bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS technology. The medial or lateral femoral condyle will be replaced using our novel instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed and used to replace the entire medial or lateral tibial condyle while sparing the attachments of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated using commercial available implants used for bone fixation. In the event that the meniscus has been detached from the tibial plateau during graft harvest, the periphery of the meniscus will be sutured to the capsule following standard meniscus transplant procedure.

Patients will undergo controlled post-operative rehabilitation according to standard protocols for osteochondral with concurrent meniscus allografts.

Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Osteoarthritis

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Missouri Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty

Description

Inclusion Criteria:

1. Patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
2. The subject is able and willing to consent to participate in the study

Exclusion Criteria:

1. Acute injury to any other part of the affected lower extremity
2. The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
3. BMI > 40
4. Age > 50 at the time of enrollment
5. The subject is either pregnant, or a prisoner
6. Currently involved in a workers' compensation case at the time of enrollment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post-traumatic knee OA; post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale Pain Score	patient reported Visual Analogue Scale Pain Score, 0 no pain, 10 maximum pain	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tegner Activity Level Scale	Patient reported outcome scale related to work and sporting activities, The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.	12 months
International Knee Documentation Committee (IKDC) Total Score	Knee specific patient reported outcome, ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.	12 months
PROMIS - Physical Function and Mobility	A survey related to physical function and mobility, T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. A higher score is better for this outcome measure as it indicates more function/mobility compared to the mean of the reference population.	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2002751

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No