NCT06332352

Brief Summary

Platelets are small cells found in the blood that help form clots and stop bleeding. Platelet-rich plasma is blood that contains more platelets than normal and can be given to help people with pain. Tears of the Labrum to the hip (the cartilage "suction cup" that holds the ball to the socket of the hip) cause hip pain. The study wants to see if a portion of the patient's blood, the platelets, will help relieve hip pain and function. Participation requires completing surveys by email, text message, in person, and/or by telephone. Medical tests will also be done to track the health of participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 1, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

March 1, 2024

Results QC Date

April 30, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

Acetabular Labrum TearPlatelet Rich Plasma

Outcome Measures

Primary Outcomes (3)

  • Global Assessment Score

    Global patient satisfaction was assessed prospectively at 6 months following the intervention using a numeric rating scale ranging from 0 to 100. Participants were asked to rate their hip, where 0 represented "worst possible" and 100 represented "best possible." The score reflects the participant's overall perception of their injection, including symptom improvement and overall experience.

    6 Months

  • International Hip Outcome Tool (iHOT-12)

    Description: The International Hip Outcome Tool-12 (iHOT-12) is a validated, patient-reported outcome measure designed to assess symptoms, functional limitations, and quality of life in young, active individuals with hip disorders. Structure: The iHOT-12 consists of 12 items that capture four domains: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns Each item is presented as a visual analog scale (VAS). Scoring: Each item is scored from 0 to 100. 0 = severe symptoms/extreme limitations 100 = no symptoms/no limitations The overall score is calculated as the mean of all answered items (range 0-100), with higher scores indicating better hip function and quality of life.

    6 Months

  • EQ VAS (EuroQual Visual Analog Scale)

    The EQ Visual Analog Scale (EQ VAS) was used to assess participants' self-rated overall health at the primary end-point. Participants rated their health on a scale from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Higher scores indicate better perceived health status.

    6 Months

Study Arms (1)

Intra-Articular hip injection of PRP

EXPERIMENTAL

Single Group Assignment Recruitment will occur at the University of Utah Orthopedic Center by physician and study staff members medical chart review before patient visits. 45 mL of blood will be collected from eligible participants and processed. A single processed neutrophil-poor PRP injection will be given once to a single hip.

Biological: PRP

Interventions

PRPBIOLOGICAL

Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint.

Intra-Articular hip injection of PRP

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≤49 years old (i.e., 18 - 49 years old)
  • Hip or groin pain with at least 1 positive provocative labral hip maneuver (i.e., Flexion, Adduction, Internal Rotation (FADIR) test, subspine impingement test, scour)
  • Radiographs with Tonnis grade \< 2 (i.e., 0 or 1)
  • MRI or MRA hip with evidence of acetabular labral tear
  • Failure of at least 6 weeks of conservative management \[i.e., activity modification, non-steroidal anti-inflammatory drugs (NSAIDs), and/or physical therapy (PT), other intra-articular injection etc.\]
  • Prior diagnostic ultrasound guided hip injection with anesthetic-only providing ≥50% pain relief

You may not qualify if:

  • Any prior surgery to the affected hip
  • Imaging with evidence of avascular necrosis of the affected hip
  • Imaging with evidence of hip dysplasia (i.e. lateral center edge angle of ≤20 degrees)
  • Alpha angle of ≥55 degrees of the affected hip
  • Intra-articular hip injection within the last 6 months to the affected hip of any injectate with the exception of anesthetic
  • Active systemic infection requiring antibiotics or local infection at the site of the injection
  • Any prior intra-articular infection of the affected hip
  • Any prior fracture of the affected femur or pelvis
  • Blood dyscrasia or malignancy
  • Non-ambulatory patients
  • Patient seeking care with active litigation pending
  • Body mass index (BMI) ≥ 35 kg/m2
  • Systemic inflammatory arthropathy
  • Oral steroids consumed within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah - Department of Orthopaedics

Salt Lake City, Utah, 84108, United States

Location

Related Publications (13)

  • Groh MM, Herrera J. A comprehensive review of hip labral tears. Curr Rev Musculoskelet Med. 2009 Jun;2(2):105-17. doi: 10.1007/s12178-009-9052-9. Epub 2009 Apr 7.

    PMID: 19468871BACKGROUND
  • Ishoi L, Nielsen MF, Krommes K, Husted RS, Holmich P, Pedersen LL, Thorborg K. Femoroacetabular impingement syndrome and labral injuries: grading the evidence on diagnosis and non-operative treatment-a statement paper commissioned by the Danish Society of Sports Physical Therapy (DSSF). Br J Sports Med. 2021 Nov;55(22):1301-1310. doi: 10.1136/bjsports-2021-104060. Epub 2021 Sep 16.

    PMID: 34531185BACKGROUND
  • Bsat S, Frei H, Beaule PE. The acetabular labrum: a review of its function. Bone Joint J. 2016 Jun;98-B(6):730-5. doi: 10.1302/0301-620X.98B6.37099.

    PMID: 27235512BACKGROUND
  • Su T, Chen GX, Yang L. Diagnosis and treatment of labral tear. Chin Med J (Engl). 2019 Jan 20;132(2):211-219. doi: 10.1097/CM9.0000000000000020.

    PMID: 30614856BACKGROUND
  • 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
  • Chinzei N, Hashimoto S, Hayashi S, Takayama K, Matsumoto T, Kuroda R. Prediction of intra-articular pathology and arthroscopic outcomes for femoroacetabular impingement and labral tear based on the response to preoperative anaesthetic hip joint injections. Eur J Orthop Surg Traumatol. 2020 May;30(4):737-742. doi: 10.1007/s00590-020-02627-0. Epub 2020 Jan 20.

    PMID: 31960159BACKGROUND
  • Yoong P, Guirguis R, Darrah R, Wijeratna M, Porteous MJ. Evaluation of ultrasound-guided diagnostic local anaesthetic hip joint injection for osteoarthritis. Skeletal Radiol. 2012 Aug;41(8):981-5. doi: 10.1007/s00256-011-1290-4. Epub 2011 Nov 10.

    PMID: 22069031BACKGROUND
  • Byrd JW, Jones KS. Diagnostic accuracy of clinical assessment, magnetic resonance imaging, magnetic resonance arthrography, and intra-articular injection in hip arthroscopy patients. Am J Sports Med. 2004 Oct-Nov;32(7):1668-74. doi: 10.1177/0363546504266480.

    PMID: 15494331BACKGROUND
  • O'Dowd A. Update on the Use of Platelet-Rich Plasma Injections in the Management of Musculoskeletal Injuries: A Systematic Review of Studies From 2014 to 2021. Orthop J Sports Med. 2022 Dec 9;10(12):23259671221140888. doi: 10.1177/23259671221140888. eCollection 2022 Dec.

    PMID: 36532150BACKGROUND
  • Saied AM, Redant C, El-Batouty M, El-Lakkany MR, El-Adl WA, Anthonissen J, Verdonk R, Audenaert EA. Accuracy of magnetic resonance studies in the detection of chondral and labral lesions in femoroacetabular impingement: systematic review and meta-analysis. BMC Musculoskelet Disord. 2017 Feb 16;18(1):83. doi: 10.1186/s12891-017-1443-2.

    PMID: 28209142BACKGROUND
  • Conaway Wea. Predictors of Outcomes of Non-Surgical Management for Acetabular Labral Tears. Orthopaedic Journal of Sports Medicine. 2018;6(3).

    BACKGROUND
  • Lim A, Zhu JB, Khanduja V. The Use of Intra-articular Platelet-Rich Plasma as a Therapeutic Intervention for Hip Osteoarthritis: A Systematic Review and Meta-analysis. Am J Sports Med. 2023 Jul;51(9):2487-2497. doi: 10.1177/03635465221095563. Epub 2022 Jun 7.

    PMID: 35971803BACKGROUND
  • De Luigi AJ, Blatz D, Karam C, Gustin Z, Gordon AH. Use of Platelet-Rich Plasma for the Treatment of Acetabular Labral Tear of the Hip: A Pilot Study. Am J Phys Med Rehabil. 2019 Nov;98(11):1010-1017. doi: 10.1097/PHM.0000000000001237.

    PMID: 31162277BACKGROUND

Limitations and Caveats

This study is limited by small sample size, convenience sampling, lack of control group, and lack of blinding. Outcomes were patient-reported without physical examination, which may have provided additional information on hip pain and function after PRP. There was wide age variability (18-49 years). Although Tonnis grade ≥2 was excluded, distinguishing traumatic labral tears from degenerative changes is difficult. Some patients required additional injections or surgery.

Results Point of Contact

Title
Primary Investigator
Organization
The University of Utah

Study Officials

  • Dan Cushman, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 27, 2024

Study Start

March 20, 2024

Primary Completion

January 31, 2026

Study Completion

March 1, 2026

Last Updated

June 25, 2026

Results First Posted

June 25, 2026

Record last verified: 2025-11

Locations