Clinical trial NCT02920177: Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Official title: Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Femoroacetabular Impingement
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Pain Score on the Visual Analog Scale
timeFrame: 12 months
Secondary outcomes:
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS
timeFrame: 12 months
measure: Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale
timeFrame: 12 months
measure: Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.
timeFrame: 12 months
measure: Change in Kellgren-Lawrence Classification Scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tariq M Awan, DO
role: PRINCIPAL_INVESTIGATOR
References: