Clinical trial NCT02183896: Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
Official title: Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Femoroacetabular Impingement
Chondral Lesions
Keywords: Femoroacetabular impingement (FAI)
Chondral lesions
Hip
Microfracture
Platelet-rich plasma (PRP)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research project is to assess the effectiveness of intra-articular injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral healing following microfracture performed during femoroacetabular impingement (FAI) hip arthroscopy.

Detailed description: The purpose of this research project is to assess the effectiveness of intra-articular injections of autologous platelet-rich plasma (PRP) after arthroscopic microfracture. Our hypothesis is that platelet-rich plasma will improve patient's clinical outcomes and chondral healing following microfracture performed during femoroacetabular impingement (FAI) hip arthroscopy.

This study has two aims:

1. Evaluate clinical efficacy of intra-articular injections of platelet-rich plasma (PRP) following arthroscopic microfracture.
2. Evaluate if microfracture followed by PRP injections improves chondral healing.

Microfracture has shown good results with chondral lesions of the hip. However, microfracture does not regenerate normal hyaline cartilage. There is growing evidence that PRP can improve articular cartilage healing. Injection of PRP following microfracture may help regeneration to normal hyaline like articular cartilage together with soft tissue healing, thereby improving patients' early and long-term outcomes of chondral healing.

Patients will be randomized to one of two study arms - microfracture with PRP (treatment arm) and microfracture with saline (control arm) in a 1:1 ratio.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18-50, inclusive.
2. Healthy patients undergoing hip arthroscopy due to FAI.
3. No OA according to X-Ray, defined by the presence of joint space narrowing, osteophytes, sclerosis and subchondral cysts and surgery observation (Tonnis grade 0-1).
4. No other influential disabilities in lower limbs, which could alter the post-operative therapy.
5. No chronic use of NSAIDs, steroids, or chemotherapy drugs during the last 6 months before enrollment.
6. Women of childbearing potential will be allowed to enroll but must be willing to practice one highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device \[IUD\] or intrauterine system \[IUS\] condom or occlusive cap with spermicidal foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout the study.
7. Intra-articular cartilage lesion grade 2-3-4-5 of Beck Classification or III-IV of Outerbridge.

Exclusion Criteria:

1. Patients with autoimmune concomitant disease(s) that may affect joints, such as rheumatoid arthritis (RA), psoriatic arthritis and lupus arthritis.
2. Patients with polyarticular disease.
3. Patients with major conditions, such as poorly controlled diabetes, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) or untreated depression.
4. Patients with blood disorders (thrombopathy, thrombocytopenia, anemia with hemoglobin \<9g/dL).
5. Patients who had intra-articular treatment with steroids within 6 months of enrollment in this study or received more than 3 previous intra-articular steroid injections to the effected hip.
6. Patients who are pregnant or nursing at the time of consent.
7. Non-English speaking patients. (Scores used for evaluation have not been validated in Spanish).
8. Patients who had previous hip surgery.
9. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
10. Chronic use of NSAIDs (defined as taking NSAID regularly every week for the last 6 months), steroids or chemotherapy drugs.
11. Patients with a BMI over 30. Due to the fact that this study utilizes an injection technique, which may be inaccurate in obese subjects.
12. Patients with pacemakers or metal implants who are unable to get an MRI.
13. Non-adherence according to inclusion criteria.
14. Patients allergic to lidocaine

Primary outcomes:
measure: MRI dGEMRIC
timeFrame: 12 and 24 months post-operative
Secondary outcomes:
measure: PA Hip X-Ray
timeFrame: Baseline, 12 and 24 months post-operative
measure: International Hip Outcome Tool (IHOT)
timeFrame: Pre-operative; and 3, 6, 12, and 24 month post-operative
measure: Western Ontario and McMaster (WOMAC) osteoarthritis index
timeFrame: Pre-operative; and 3, 6, 12, and 24 month post-operative
measure: Non-arthritic hip score
timeFrame: Pre-operative; and 3, 6, 12, and 24 month post-operative
measure: Range of Motion (ROM)
timeFrame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
measure: Flexion Abduction and External Rotation (FABER)
timeFrame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
measure: Bicycle Kicks
timeFrame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Denver, CU Sports Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cecilia Pascual-Garrido, M.D.
role: PRINCIPAL_INVESTIGATOR
References: