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

NCT ID: NCT02920177

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2018-08-10

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

platelet-rich plasma

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

Group Type: EXPERIMENTAL

platelet-rich plasma injection

Intervention Type: DRUG

platelet-rich plasma injection

Kenalog 10 mg/mL Injectable Suspension

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

Group Type: ACTIVE_COMPARATOR

Kenalog 10 MG/ML Injectable Suspension

Intervention Type: DRUG

4 mL corticosteroid injection

Interventions

platelet-rich plasma injection

platelet-rich plasma injection

Intervention Type: DRUG

Kenalog 10 MG/ML Injectable Suspension

4 mL corticosteroid injection

Intervention Type: DRUG

Other Intervention Names

PRP

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Tariq Awan

Assistant Professor in Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tariq M Awan, DO

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00104340

Identifier Type: -

Identifier Source: org_study_id