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

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University of Michigan

Status and phase

Terminated
Phase 4

Conditions

Femoroacetabular Impingement

Treatments

Drug: platelet-rich plasma injection
Drug: Kenalog 10 MG/ML Injectable Suspension

Study type

Interventional

Funder types

Other

Identifiers

NCT02920177
HUM00104340

Details and patient eligibility

About

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).

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4 participants in 2 patient groups

platelet-rich plasma
Experimental group
Description:
platelet-rich plasma injection into the head-neck junction of the hip joint
Treatment:
Drug: platelet-rich plasma injection
Kenalog 10 mg/mL Injectable Suspension
Active Comparator group
Description:
corticosteroid injection into the head-neck junction of the hip joint
Treatment:
Drug: Kenalog 10 MG/ML Injectable Suspension

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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