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

• Sponsor: University of Missouri-Columbia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03719417
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Post-traumatic Osteoarthritis	Procedure: Unicompartmental Biologic Arthroplasty; Procedure: Extensive Biologic Arthroplasty	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
• Actual Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. VAS Pain Score (Visual Analog Scale) [12 Months]

   This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain

Secondary Outcome Measures

1. International Knee Documentation Committee Score (IKDC) [12 Months]

   This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function score.

2. Single Assessment Numeric Evaluation (SANE) score [12 Months]

   This score looks at what the patient rates their knee with 100% being normal, and 0% being as far from normal as possible

3. PROMIS Mobility [12 Months]

   This looks at mobility and function on a scale of 14.1 to 61.7 with higher scores equaling higher mobility

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Missouri Orthopaedic Institute	Columbia	Missouri	United States	65202

Sponsors and Collaborators

• University of Missouri-Columbia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: James Stannard, Professor, Orthopedic Surgery, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT03719417
• Other Study ID Numbers: 2011153
• First Posted: Oct 25, 2018
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by James Stannard, Professor, Orthopedic Surgery, University of Missouri-Columbia: Knee Pain
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Mar 25, 2022