Femoroacetabular ImpingementPhase 4NCT02920177

Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement

A Phase 4 study testing platelet-rich plasma injection and Kenalog 10 MG/ML Injectable Suspension in people with Femoroacetabular Impingement, run by University of Michigan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the clinical response of intra-articular platelet rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular impingement (FAI). Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Femoroacetabular Impingement
What is being tested?: platelet-rich plasma injection and Kenalog 10 MG/ML Injectable Suspension
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2016to 10 Aug 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients with symptomatic FAI
Clinical and radiographic evidence of FAI
Patients able to provide consent to study participation
Completion of 6 weeks of physical therapy program

Who cannot join

Established Osteoarthritis (Kellgren-Lawrence > 3)
Minimum joint space > 2 mm as measured on AP radiograph
Hip dysplasia (center edge angle < 20° on AP radiograph)
Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes
Patients with ongoing infection including HIV and Hepatitis
Patient with history of osteomyelitis/septic arthritis

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Anticoagulation therapy
Patients who are pregnant or breast feeding
Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis
Patients taking immunosuppressant medication
Patients with abnormal hematology or serum chemistry lab results
Patients receiving injection to treatment knee within 2 months of study enrollment
BMI greater than 35 or less than 20

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Hospital
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

The purpose of this study is to compare the clinical response of intra-articular platelet rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular impingement (FAI).

Read the detailed description

This study will determine if PRP treatment of FAI improves (i) patient reported outcome scores and (ii) hip functional stability compared to standard corticosteroid treatment and if PRP treatment of FAI reduces (i) radiographic and (ii) biochemical markers of joint inflammation and cartilage degradation.

Conditions: Femoroacetabular Impingement
Being tested: platelet-rich plasma injection, Kenalog 10 MG/ML Injectable Suspension
Medical subject headings: Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

platelet-rich plasma injectionDrug
Also called PRP
platelet-rich plasma injection
Kenalog 10 MG/ML Injectable SuspensionDrug
4 mL corticosteroid injection

Study groups in NCT02920177
Study group	Role	What they receive
platelet-rich plasma	Experimental	platelet-rich plasma injection into the head-neck junction of the hip joint Receives: Drug: platelet-rich plasma injection
Kenalog 10 mg/mL Injectable Suspension	Active comparator	corticosteroid injection into the head-neck junction of the hip joint Receives: Drug: Kenalog 10 MG/ML Injectable Suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Pain Score on the Visual Analog Scale
VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 12 months

Secondary outcomes (4)

Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS
Measure Description: Hip Disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.
The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.
The questions that are included in the WOMAC are a subgroup of questions that are included in the HOOS, so because of this the HOOS survey can also be used to calculate the WOMAC score for patients.
Measured: 12 months
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. Global mental health scores range from 0 - 100, and higher scores indicate better mental health.
Global physical health measures overall physical health, physical function, pain and fatigue. Physical global health scores range from 0 - 100, and higher scores indicate better physical health.
Measured: 12 months
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
Measured: 12 months
Change in Kellgren-Lawrence Classification Scores
Calculated from anterior-posterior (AP) pelvis radiographs. Kellgren Lawrence grading system was intended to be utilized analyzing pre-treatment and post-treatment radiographs of the knee. Grading is from 1 to 4 with 1 being minimal to mild disease and 4 being end stage joint disease.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201610 Aug 2018

First posted30 Sep 2016 (estimated)
Study start1 Aug 2016
Primary completion10 Aug 2018
Study completion10 Aug 2018

Why it stopped: low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02920177
Sponsor's protocol ID: HUM00104340
Status last verified: Mar 2020
First submitted: 30 Aug 2016
Last updated: 3 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
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The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
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Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
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Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
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Mapping Joint Damage Patterns in Femoroacetabular Impingement
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All Femoroacetabular Impingement trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
ClinicalTrials.gov ID: NCT02920177
Acronym / sponsor ID: HUM00104340
Conditions: Femoroacetabular Impingement
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: low enrollment
Enrolment: 4 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 1 Aug 2016 (actual)
Primary completion: 10 Aug 2018 (actual)
Study completion: 10 Aug 2018 (actual)
First posted: 30 Sep 2016 (estimated)
Results: Posted 3 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the clinical response of intra-articular platelet rich plasma (PRP) versus corticosteroid injection in patients affected by femoroacetabular impingement (FAI).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
platelet-rich plasma	Experimental	Drug: platelet-rich plasma injectionplatelet-rich plasma injection into the head-neck junction of the hip joint
Kenalog 10 mg/mL Injectable Suspension	Active comparator	Drug: Kenalog 10 MG/ML Injectable Suspensioncorticosteroid injection into the head-neck junction of the hip joint

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients with symptomatic FAI
Clinical and radiographic evidence of FAI
Patients able to provide consent to study participation
Completion of 6 weeks of physical therapy program

Key exclusion criteria (13 listed)

Established Osteoarthritis (Kellgren-Lawrence > 3)
Minimum joint space > 2 mm as measured on AP radiograph
Hip dysplasia (center edge angle < 20° on AP radiograph)
Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes
Patients with ongoing infection including HIV and Hepatitis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
platelet-rich plasma injectionAlso: PRPplatelet-rich plasma injection	Drug	platelet-rich plasma
Kenalog 10 MG/ML Injectable Suspension4 mL corticosteroid injection	Drug	Kenalog 10 mg/mL Injectable Suspension

Primary outcome

Change From Baseline in Pain Score on the Visual Analog Scale
Time frame: 12 months
VAS score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

4 secondary outcomes

Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS
Time frame: 12 months
Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
Time frame: 12 months
Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
Time frame: 12 months
Change in Kellgren-Lawrence Classification Scores
Time frame: 12 months

Results and safety

Results posted to the registry on 3 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Platelet-rich Plasma	2	0
Kenalog 10 mg/mL Injectable Suspension	2	0

Primary outcome: Change From Baseline in Pain Score on the Visual Analog Scale

Time frame: 12 months

Population analysed: No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Platelet-rich Plasma	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Kenalog 10 mg/mL Injectable Suspension	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Recruitment was supposed to take place in the first year, but was extended due to low enrollment. The study was terminated early due to an inability to enroll subjects. All participants left the study before outcome measure data could be collected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Femoroacetabular Impingement

RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tariq M Awan, DO principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Pain Score on the Visual Analog Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02920177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.