Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02582489
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Intervention/treatment Phase
Osteoarthritis Post-meniscectomy Biological: Bone Marrow Aspirate Concentrate Procedure: Standard Meniscectomy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 : December 22, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Biological: Bone Marrow Aspirate Concentrate
Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.

Procedure: Standard Meniscectomy
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.
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.
 Procedure: Standard Meniscectomy
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. International Knee Documentation Committee (IKDC) Score [ Time Frame: One Year ]
    The primary outcome measure will be the IKDC score at one year follow-up


Secondary Outcome Measures :
  1. Patient reported outcomes throughout follow-up period [ Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  2. Synovial fluid analysis [ Time Frame: 2 weeks, 6 weeks ]
    To investigate any changes in synovial fluid markers of osteoarthritis.

  3. Radiographic analysis [ Time Frame: 1 year, 2 years ]
    The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years.

  4. Patient reported outcomes throughout follow-up period [ Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    Visual Analog Score (VAS)

  5. Patient reported outcomes throughout follow-up period [ Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    International Knee Documentation Committee form (IKDC)

  6. Patient reported outcomes throughout follow-up period [ Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    Knee injury and Osteoarthritis Outcome Score (KOOS)

  7. Patient reported outcomes throughout follow-up period [ Time Frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
    (Short Form Health Survey) SF-12


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582489


Contacts
Layout table for location contacts
Contact: Carla Edwards, PhD 312-563-5735 carla_edwards@rush.edu

Locations
Layout table for location information
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Barb L Ramsey, RN    312-563-2883      
Principal Investigator: Brian J Cole, MD, MBA         
Sub-Investigator: Nikhil N Verma, MD         
Sub-Investigator: Adam B Yanke, MD         
Sponsors and Collaborators
Rush University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Brian J Cole, MD, MBA Midwest Orthopaedics at Rush
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02582489    
Other Study ID Numbers: 15090903
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rush University Medical Center:
Mesenchymal stem cells
Bone marrow aspirate concentrate
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases