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NCT Number: NCT02582489

Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Post-meniscectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone Marrow Aspirate Concentrate

Biological

Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.

Standard Meniscectomy

Procedure

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

Primary outcomes

  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 outcomes

  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 (VAS)

    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 (IKDC)

    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 (KOOS)

    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 (SF-12)

    Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

    (Short Form Health Survey) SF-12

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2015
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.