Recruiting
Phase 3

PRP, PPP, BMAC

Sponsor:

Massachusetts General Hospital

Code:

NCT06003101

Conditions

Acetabular Labrum Tear

Femoro Acetabular Impingement

Chondral Defect

Bone Marrow Aspirate Concentrate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bone marrow aspirate concentrate (BMAC)

Control

Study Details

Brief summary:

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?

Conditions

Acetabular Labrum Tear

Femoro Acetabular Impingement

Chondral Defect

Bone Marrow Aspirate Concentrate

Study ID

NCT06003101

Start date

Aug 30, 2023

Status verified date

Nov, 2024

Completion date

Aug 30, 2045

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age: > or equal to 18 years
  • Clinically indicated for hip arthroscopy (by the study PI) to address a labral pathology
  • Willingness to participate, amenable to randomization into either treatment arm of the research study, and the ability to understand \& sign the informed consent document

Exclusion Criteria:

  • Non-English speaking (PROM surveys are only validated in English)
  • Prior same site (i.e., ipsilateral hip) surgery, including but not limited to previous hip arthroscopy, core decompression, or periacetabular osteotomies

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Bone marrow aspirate concentrate (BMAC)

Bone marrow aspiration from the body of the ilium will be performed through one of the arthroscopic portals.

Control

Standard of care hip arthroscopy without bone marrow aspiration will be performed in these patients.

Primary outcome measure

  • Pain Level [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
  • Modified Harris Hip Score (mHHS) [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
  • International Hip Outcome Tool-12 (iHOT-12) [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
  • Non-Arthritic Hip Score (NAHS) [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
  • Hip Outcome Score (HOS) [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
  • Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
  • Visual Analog Scale (VAS) Pain Score [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

Central Contacts and Locations

Central contacts

Scott D. Martin, MD

617-732-5329sdmartin@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 20, 2024

Last verified

Nov, 2024

Keywords

  • Acetabular Labrum Tear
  • Femoro Acetabular Impingement
  • Chondral Defect
  • Bone Marrow Aspirate Concentrate
  • Chondrolabral Junction
  • Osteoarthritis
  • Hip Arthroscopy
  • BMAC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2024-11-20.