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NCT02582489 | RECRUITING | Osteoarthritis Post-meniscectomy

Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
Sponsor:

Rush University Medical Center

Brief 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.

Condition or disease

Osteoarthritis Post-meniscectomy

Intervention/treatment

Bone Marrow Aspirate Concentrate

Standard Meniscectomy

Phase

NA

Detailed Description:

Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection. This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
Official Title : Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
Actual Study Start Date : 2017-12-22
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 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
Exclusion Criteria
  • * Any subject lacking decisional capability
  • * Unwillingness to participate in the necessary follow-up
  • * Subject is pregnant or may become pregnant
  • * History of diabetes mellitus
  • * History of rheumatoid arthritis or other autoimmune disorder
  • * History of solid organ or hematologic transplantation
  • * Diagnosis of a non-basal cell malignancy within the preceding 5 years
  • * Infection requiring antibiotic treatment within the preceding 3 months
  • * Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views
  • * Prior surgery on the index meniscus
  • * Concomitant surgery such as ligament surgery or cartilage repair or restoration
  • * Infection
  • * Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks
Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

Location Details

NCT02582489

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Locations

RECRUITING

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612