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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.
Acetabular labral tears (ALT) have been reported to have a prevalence of 22-55% in patients presenting with hip or groin pain. Etiologies of ALT include femoral acetabular impingement (FAI) as the most common followed by trauma, degeneration, dysplasia, hypermobility, etc. The fibrocartilaginous acetabular labrum is an important structure in the maintenance of hip perseveration and biomechanics. Several functions include decreasing stress on articular surfaces by increasing surface contact area, maintaining a pressurized layer of intra-articular fluid to distribute mechanical forces, and assisting in joint stability. The consequences of labral pathology are not fully understood, however, prior studies have indicated that there is a correlation between acetabular labral lesions and chondral injury contributing to the development of early degenerative hip disease.
Based on current evidence, it is suggested that the highest degree of clinical accuracy in the diagnosis of a symptomatic acetabular labral tear is with a combination of clinical history, physical examination, advanced imaging such as magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA), and diagnostic injection. Conservative management trials are often considered for initial treatment and include relative rest, activity modification, anti-inflammatory medication, and physical therapy with the potential for intra-articular injections including corticosteroids. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered. If conservative management is unsuccessful, arthroscopic intervention with resection, refixation, or reconstruction is often considered.
According to a recent systematic review and meta-analysis, there is promising evidence that platelet rich plasma (PRP) is an effective treatment for hip osteoarthritis. However, there is limited evidence regarding PRP treatment for ALT. To date, there is only one pilot study published evaluating 8 patients diagnosed with ALT who underwent ultrasound guided intra-articular hip injection with PRP. Optimistically, this study did reveal significant differences from baseline in function and pain scores at short term follow-up. However, the study lacked many important details including information about the injectate (the composition of the blood and PRP) which is vital to include in studies of these types. Therefore, the purpose of this study is to fully evaluate the effects of PRP treatment on the clinical outcomes of ALT prospectively in a larger cohort of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological | Intra-articular hip injection of PRP, Blood Collection 45mL, Processed Neutrophil-Poor PRP, 1 injection to one hip joint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Cushman, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah - Department of Orthopaedics | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19468871 | Background | 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. | |
| 34531185 | Background | 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. |
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This was an open-label study; therefore, no randomization was performed. In some cases, participants had more than one hip enrolled, accounting for the difference between the number of participants (n=28) and the number of units/hips enrolled (n=30).
Patients were recruited from March through December 2024. Patients were clinically diagnosed with a symptomatic acetabular labral tear by a primary care or orthopedic sports medicine physician in a tertiary outpatient, orthopedic clinic setting. Patients who met inclusion criteria were referred to the study and given the option of participation.
| ID | Title | Description |
|---|---|---|
| FG000 | Intra-Articular Hip Injection of PRP | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed.
| ID | Title | Description |
|---|---|---|
| BG000 | Intra-Articular Hip Injection of PRP | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. | Posted | Median | Inter-Quartile Range | score on a scale | 6 Months | Hips | Hips |
|
From enrollment until the end of follow-up, up to one month
Twenty-eight participants were at risk of an adverse event. However since some participants (n=2) had both hips enrolled in the study, there is a difference between the number of participants (n=28) and the number of hips (n=30) analyzed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intra-Articular Hip Injection of PRP | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase pain in the hip | Musculoskeletal and connective tissue disorders | Systematic Assessment | Among those who reported increased hip pain following injection, the average pain intensity was 6.2/10 and lasted an average of 5.2 days. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Primary Investigator | The University of Utah | 801-587-5458 | Dan.Cushman@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2024 | Apr 28, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2024 | Apr 28, 2026 | ICF_001.pdf |
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| 27235512 | Background | 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. |
| 30614856 | Background | 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. |
| 11764355 | Background | 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. |
| 31960159 | Background | 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. |
| 22069031 | Background | 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. |
| 15494331 | Background | 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. |
| 36532150 | Background | 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. |
| 28209142 | Background | 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. |
| Background | Conaway Wea. Predictors of Outcomes of Non-Surgical Management for Acetabular Labral Tears. Orthopaedic Journal of Sports Medicine. 2018;6(3). |
| 35971803 | 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. |
| 31162277 | Background | 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. |
| Hips |
|
| Median |
| Inter-Quartile Range |
| Years |
| Participants |
|
|
| Sex: Female, Male | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| BMI | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. | Median | Inter-Quartile Range | kg/m^2 | Participants |
|
|
| Duration of symptoms | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. | Median | Inter-Quartile Range | Months | Participants |
|
|
| Global Assessment Score | Global patient satisfaction was assessed at baseline prior to 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. | Median | Inter-Quartile Range | score on a scale | Hips |
|
|
| International Hip Outcome Tool (iHOT-12) | 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. | Median | Inter-Quartile Range | score on a scale | Hips |
|
|
| EQ VAS (EuroQual Visual Analog Scale) | The EQ Visual Analog Scale (EQ VAS) was used to assess participants' self-rated overall health at baseline. 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. | Median | Inter-Quartile Range | score on a scale | Hips |
|
|
|
|
| Primary | 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. | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. | Posted | Median | Inter-Quartile Range | Scores on a scale | 6 Months | Hips | Hips |
|
|
|
| Primary | 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. | Some participants had two different hips enrolled in the study, which explains the difference between the number of participants and the number of hips (units) analyzed. | Posted | Median | Inter-Quartile Range | Scores on a scale | 6 Months | Hips | Hips |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 16 |
| 28 |
|
| Reduced hip range of motion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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