Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject is greater than 18 years old

• Written informed consent is obtained

• Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy

• Meniscal pathology is confirmed through MRI and arthroscopically

• Subject agrees to all follow-up evaluations

• Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Carla Edwards, PhD
carla_edwards@rush.edu
312-563-5735
Time Frame
Start Date: 2017-12-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)
Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.
Placebo_comparator: Meniscectomy with Placebo
Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov