NCT06003101

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. 1.Does PRP/PPP/BMAC application improve functional outcomes after hip arthroscopy to address acetabular labral pathologies?
  2. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
235mo left

Started Aug 2023

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Aug 2023Aug 2045

First Submitted

Initial submission to the registry

August 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
18 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2045

Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

August 14, 2023

Last Update Submit

November 18, 2024

Conditions

Acetabular Labrum TearFemoro Acetabular ImpingementChondral DefectBone Marrow Aspirate Concentrate

Keywords

Acetabular Labrum TearFemoro Acetabular ImpingementChondral DefectBone Marrow Aspirate ConcentrateChondrolabral JunctionOsteoarthritisHip ArthroscopyBMAC

Outcome Measures

Primary Outcomes (7)

  • 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.

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

  • 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).

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

  • 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.

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

  • 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).

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

  • Hip Outcome Score (HOS)

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

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

  • Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score

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

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

  • Visual Analog Scale (VAS) Pain Score

    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.

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

Secondary Outcomes (5)

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

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

  • Tegner Lysholm Knee Scoring Scale

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

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

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

  • The Pittsburgh Sleep Quality Index (PSQI):

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

  • Patient Satisfaction, Postoperative Protocol Compliance, & Subsequent Surgeries

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

Study Arms (2)

Bone marrow aspirate concentrate (BMAC)

EXPERIMENTAL

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.

Biological: Bone marrow aspirate concentrate (BMAC)

Control

PLACEBO COMPARATOR

Patients allocated to the control cohort will receive standard of care hip arthroscopy without PRP/PPP/BMAC application.

Procedure: Control

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.

Bone marrow aspirate concentrate (BMAC)
ControlPROCEDURE

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (15)

  • Bedi A, Kelly BT. Femoroacetabular impingement. J Bone Joint Surg Am. 2013 Jan 2;95(1):82-92. doi: 10.2106/JBJS.K.01219.

    PMID: 23283377BACKGROUND

  • Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.

    PMID: 16376242BACKGROUND

  • McCarthy JC, Jarrett BT, Ojeifo O, Lee JA, Bragdon CR. What factors influence long-term survivorship after hip arthroscopy? Clin Orthop Relat Res. 2011 Feb;469(2):362-71. doi: 10.1007/s11999-010-1559-2.

    PMID: 20872105BACKGROUND

  • McCarthy JC, Noble PC, Schuck MR, Wright J, Lee J. The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease. Clin Orthop Relat Res. 2001 Dec;(393):25-37. doi: 10.1097/00003086-200112000-00004.

    PMID: 11764355BACKGROUND

  • Ferguson SJ, Bryant JT, Ganz R, Ito K. The acetabular labrum seal: a poroelastic finite element model. Clin Biomech (Bristol). 2000 Jul;15(6):463-8. doi: 10.1016/s0268-0033(99)00099-6.

    PMID: 10771126BACKGROUND

  • Ferguson SJ, Bryant JT, Ganz R, Ito K. An in vitro investigation of the acetabular labral seal in hip joint mechanics. J Biomech. 2003 Feb;36(2):171-8. doi: 10.1016/s0021-9290(02)00365-2.

    PMID: 12547354BACKGROUND

  • Ferguson SJ, Bryant JT, Ganz R, Ito K. The influence of the acetabular labrum on hip joint cartilage consolidation: a poroelastic finite element model. J Biomech. 2000 Aug;33(8):953-60. doi: 10.1016/s0021-9290(00)00042-7.

    PMID: 10828325BACKGROUND

  • Larson CM, Giveans MR. Arthroscopic management of femoroacetabular impingement: early outcomes measures. Arthroscopy. 2008 May;24(5):540-6. doi: 10.1016/j.arthro.2007.11.007. Epub 2008 Jan 7.

    PMID: 18442686BACKGROUND

  • Larson CM, Dean RS, McGaver RS, Seiffert KJ, Giveans MR. Arthroscopic Debridement Versus Refixation of the Acetabular Labrum Associated With Femoroacetabular Impingement: Updated Mean 7-Year Follow-up. Am J Sports Med. 2022 Mar;50(3):731-738. doi: 10.1177/03635465211067818. Epub 2022 Jan 31.

    PMID: 35099305BACKGROUND

  • Larson CM, Giveans MR, Stone RM. Arthroscopic debridement versus refixation of the acetabular labrum associated with femoroacetabular impingement: mean 3.5-year follow-up. Am J Sports Med. 2012 May;40(5):1015-21. doi: 10.1177/0363546511434578. Epub 2012 Feb 3.

    PMID: 22307078BACKGROUND

  • Espinosa N, Rothenfluh DA, Beck M, Ganz R, Leunig M. Treatment of femoro-acetabular impingement: preliminary results of labral refixation. J Bone Joint Surg Am. 2006 May;88(5):925-35. doi: 10.2106/JBJS.E.00290.

    PMID: 16651565BACKGROUND

  • Kucharik MP, Abraham PF, Nazal MR, Varady NH, Eberlin CT, Meek WM, Martin SD. Arthroscopic Acetabular Labral Repair Versus Labral Debridement: Long-term Survivorship and Functional Outcomes. Orthop J Sports Med. 2022 Jul 7;10(7):23259671221109012. doi: 10.1177/23259671221109012. eCollection 2022 Jul.

    PMID: 35837442BACKGROUND

  • Kucharik MP, Abraham PF, Nazal MR, Varady NH, Meek WM, Martin SD. Minimum 2-Year Functional Outcomes of Patients Undergoing Capsular Autograft Hip Labral Reconstruction. Am J Sports Med. 2021 Aug;49(10):2659-2667. doi: 10.1177/03635465211026666. Epub 2021 Jul 2.

    PMID: 34213975BACKGROUND

  • Martin SD, Kucharik MP, Abraham PF, Nazal MR, Meek WM, Varady NH. Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. J Bone Joint Surg Am. 2022 Jan 5;104(1):4-14. doi: 10.2106/JBJS.20.01740.

    PMID: 34648479BACKGROUND

  • Nazal MR, McCarthy MBR, Mazzocca AD, Martin SD. Connective Tissue Progenitor Analysis of Bone Marrow Aspirate Concentrate Harvested From the Body of the Ilium During Arthroscopic Acetabular Labral Repair. Arthroscopy. 2020 May;36(5):1311-1320. doi: 10.1016/j.arthro.2019.11.125. Epub 2020 Jan 17.

    PMID: 31958539BACKGROUND

MeSH Terms

Conditions

Femoracetabular ImpingementOsteoarthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisRheumatic Diseases

Study Officials

  • Scott D. Martin, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott D. Martin, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Director, Joint Preservation Service; Director, MGH Sports Medicine Fellowship

Study Record Dates

First Submitted

August 14, 2023

First Posted

August 21, 2023

Study Start

August 30, 2023

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

August 30, 2045

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)