Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
NCT ID: NCT02183896
Last Updated: 2018-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-07-31
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Platelet-rich plasma (PRP)
Intra-articular injections in the hip of autologous platelet-rich plasma (PRP) at week 1 and 2 post-operatively. Dose 5 mL. PRP is derived from the patient's own blood.
Platelet-rich plasma (PRP)
Saline
Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.
Saline
Interventions
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Platelet-rich plasma (PRP)
Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
14. Patients allergic to lidocaine
Exclusion Criteria
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.
18 Years
50 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Cecilia Pascual-Garrido, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver, CU Sports Medicine
Boulder, Colorado, United States
Countries
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Other Identifiers
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14-0080
Identifier Type: -
Identifier Source: org_study_id