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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719417
• Other study ID #: 2011153
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 31, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Post-traumatic Osteoarthritis

Intervention

Procedure:
• Unicompartmental Biologic Arthroplasty
Unicompartmental Biologic Arthroplasty surgery.
• Extensive Biologic Arthroplasty
Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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