Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip

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.

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