Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06003101
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Acetabular Labrum Tear
  • Bone Marrow Aspirate Concentrate
  • Chondral Defect
  • Femoro Acetabular Impingement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bone marrow aspirate concentrate (BMAC) — BIOLOGICAL
    Bone marrow aspiration from the body of the ilium will be performed through one of the arthroscopic portals.
  • Control — PROCEDURE
    Standard of care hip arthroscopy without bone marrow aspiration will be performed in these patients.

Study Details

The goal of this clinical trial is to assess the effect of PRP/PPP/BMAC application on functional outcomes after hip arthroscopy to address acetabular labral pathologies. The main questions it aims to answer are: 1. Does PRP/PPP/BMAC application improve functional outcomes after hip arthroscopy to address acetabular labral pathologies? 2. Does PRP/PPP/BMAC application reduce the arthritic burden as measured by functional outcomes following hip arthroscopy to address labral pathologies with concomitant PRP/PPP/BMAC application?

Key Dates

Start date
Aug 30, 2023
Status verified
Nov 2024
Primary completion
Aug 30, 2027
Completion
Aug 30, 2045

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bone marrow aspirate concentrate (BMAC)
    Patients randomly allocated to receive BMAC will undergo hip arthroscopy and will receive PRP/PPP/BMAC application through the PI's standardized method of harvest, processing, and application.
  • Placebo Comparator: Control
    Patients allocated to the control cohort will receive standard of care hip arthroscopy without PRP/PPP/BMAC application.

Primary Outcome Measure

Pain Level [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Scott D. Martin, MD

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

Related Studies