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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-10-31

Brief Summary

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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.

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Detailed Description

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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

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Knee Osteoarthritis Post-traumatic Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unicompartmental Biologic Arthroplasty

Subject will be receiving a unicompartmental biologic arthroplasty only

Group Type ACTIVE_COMPARATOR

Unicompartmental Biologic Arthroplasty

Intervention Type PROCEDURE

Unicompartmental Biologic Arthroplasty surgery.

Extensive Biologic Arthroplasty

Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently.

Group Type ACTIVE_COMPARATOR

Extensive Biologic Arthroplasty

Intervention Type PROCEDURE

Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

Interventions

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Unicompartmental Biologic Arthroplasty

Unicompartmental Biologic Arthroplasty surgery.

Intervention Type PROCEDURE

Extensive Biologic Arthroplasty

Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No