Bone Marrow Aspirate Concentrate for Osteoarthritis After Meniscectomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteoarthritis After MeniscectomyBone Marrow Aspirate Concentrate - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the outcomes of patients who receive BMAC after meniscectomy to those who don't, in terms of symptoms, physical examination, MRI, radiographs, and synovial fluid analysis. The hypothesis is that BMAC will improve outcomes.

Eligible Conditions
  • Osteoarthritis After Meniscectomy

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: One Year

1 year, 2 years
Radiographic analysis
2 weeks, 6 weeks
Synovial fluid analysis
Year 2
Patient reported outcomes throughout follow-up period
One Year
International Knee Documentation Committee (IKDC) Score

Trial Safety

Trial Design

2 Treatment Groups

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)
1 of 2
Meniscectomy with Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Bone Marrow Aspirate Concentrate · Has Placebo Group · N/A

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)Experimental Group · 2 Interventions: Bone Marrow Aspirate Concentrate, Standard Meniscectomy · Intervention Types: Biological, Procedure
Meniscectomy with Placebo
Procedure
PlaceboComparator Group · 1 Intervention: Standard Meniscectomy · Intervention Types: Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Aspirate Concentrate
2016
Completed Phase 4
~200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
389 Previous Clinical Trials
153,397 Total Patients Enrolled
Brian J Cole, MD, MBAPrincipal InvestigatorMidwest Orthopaedics at Rush

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a meniscal tear of the knee that requires a meniscectomy.
Meniscal pathology is confirmed through MRI and arthroscopically.
References