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

• Status: Withdrawn
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver

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