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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone marrow aspirate concentrate (BMAC)

    Biological/Vaccine

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

  • Control

    Procedure/Surgery

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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Bone marrow aspirate concentrate (BMAC)Experimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Level

Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Range: 0-10, with 0 being no pain and 10 being the worst pain imaginable.

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
2

Modified Harris Hip Score (mHHS)

Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
3

International Hip Outcome Tool-12 (iHOT-12)

Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. The total score is calculated as a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
4

Non-Arthritic Hip Score (NAHS)

Patient Reported Outcome Measurement (PROM) to assess the patient's functional outcomes post-surgery. Scores range from 0 (poor) to 100 (ideal).

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months

Secondary outcomes

1

Oswestry Low Back Disability Questionnaire (aka Oswestry Disability Index, ODI)

Validated PROM to assess low back pain. Scores range from 0 to 50, with 0 being no disability and 50 being completed disabled.

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
2

Tegner Lysholm Knee Scoring Scale

Validated PROM to assess knee pain. . Scores range from 0 (worse disability) to 100 (less disability).

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
3

Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)

Designed to be a "bottom-line" assessment of a patient's health that can be used for a wide variety of diseases. The PROMIS-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
4

The Pittsburgh Sleep Quality Index (PSQI):

The PQSI is a validated and widely used 9-question survey that is broken down into 7 scored subcomponents that measure the quality and patterns of sleep. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months

Other outcomes

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