Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
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| ClinicalTrials.gov Identifier: NCT02582489 |
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Recruitment Status :
Not yet recruiting
First Posted : October 21, 2015
Last Update Posted : April 14, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis Post-meniscectomy | Biological: Bone Marrow Aspirate Concentrate Procedure: Standard Meniscectomy | Not Applicable |
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 (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 |
| Estimated Study Start Date : | April 2017 |
| Estimated Primary Completion Date : | January 2019 |
| Estimated Study Completion Date : | January 2020 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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Procedure: Standard Meniscectomy
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus. |
- International Knee Documentation Committee (IKDC) Score [ Time Frame: One Year ]The primary outcome measure will be the IKDC score at one year follow-up
- 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), Visual Analog Score (VAS), International Knee Documentation Committee form (IKDC), Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-12.
- Synovial fluid analysis [ Time Frame: 2 weeks, 6 weeks ]To investigate any changes in synovial fluid markers of osteoarthritis.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 posteroanterior (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/viscoscupplemtation/PRP injection within 6 weeks
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
| Contact: Mukesh Ahuja, MBBS, MS | 312-912-4699 | mukesh.ahuja@rushortho.com |
| United States, Illinois | |
| Rush University Medical Center | Not yet 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 | |
| Principal Investigator: | Brian J Cole, MD, MBA | Midwest Orthopaedics at Rush |
Publications:
| Responsible Party: | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT02582489 History of Changes |
| Other Study ID Numbers: |
15090903 |
| First Posted: | October 21, 2015 Key Record Dates |
| Last Update Posted: | April 14, 2017 |
| Last Verified: | April 2017 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Rush University Medical Center:
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Mesenchymal stem cells Bone marrow aspirate concentrate |
Additional relevant MeSH terms:
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |