NCT03719417

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis
• Post-traumatic Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Unicompartmental Biologic Arthroplasty	Unicompartmental Biologic Arthroplasty surgery.
PROCEDURE	Extensive Biologic Arthroplasty	Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-06-01
• Completion: 2022-10-31
• First posted: 2018-10-25
• Last updated: 2022-11-02

Locations

1 site across 1 country: United States