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

NCT02920177 | Terminated Phase 4 Results DMC

• 1 other identifier: HUM00104340
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  12 months

• Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale

  12 months

• Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.

  12 months

• Change in Kellgren-Lawrence Classification Scores

  12 months

Study Arms (2)

platelet-rich plasma

EXPERIMENTAL

platelet-rich plasma injection into the head-neck junction of the hip joint

Drug: platelet-rich plasma injection

Kenalog 10 mg/mL Injectable Suspension

ACTIVE COMPARATOR

corticosteroid injection into the head-neck junction of the hip joint

Drug: Kenalog 10 MG/ML Injectable Suspension

Interventions

platelet-rich plasma injection DRUG

platelet-rich plasma injection

Also known as: PRP

platelet-rich plasma

Kenalog 10 MG/ML Injectable Suspension DRUG

4 mL corticosteroid injection

Kenalog 10 mg/mL Injectable Suspension

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

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.

Results Point of Contact

• Title: Jordyn Sessel
• Organization: University of Michigan

jsessel@med.umich.edu

734-615-0934

Study Officials

• Tariq M Awan, DO

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Orthopaedic Surgery

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 30, 2016
• Study Start: August 1, 2016
• Primary Completion: August 10, 2018
• Study Completion: August 10, 2018
• Last Updated: April 3, 2020
• Results First Posted: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)