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

NCT02183896 | Withdrawn

• 1 other identifier: 14-0080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement; Chondral Lesions

Keywords

Femoroacetabular impingement (FAI); Chondral lesions; Hip; Microfracture; Platelet-rich plasma (PRP)

Outcome Measures

Primary Outcomes (1)

• MRI dGEMRIC

  MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.

  12 and 24 months post-operative

Secondary Outcomes (7)

• PA Hip X-Ray

  Baseline, 12 and 24 months post-operative

• International Hip Outcome Tool (IHOT)

  Pre-operative; and 3, 6, 12, and 24 month post-operative

• Western Ontario and McMaster (WOMAC) osteoarthritis index

  Pre-operative; and 3, 6, 12, and 24 month post-operative

• Non-arthritic hip score

  Pre-operative; and 3, 6, 12, and 24 month post-operative

• Range of Motion (ROM)

  Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative

Study Arms (2)

Platelet-rich plasma (PRP)

EXPERIMENTAL

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.

Biological: Platelet-rich plasma (PRP)

Saline

PLACEBO COMPARATOR

Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.

Drug: Saline

Interventions

Platelet-rich plasma (PRP) BIOLOGICAL

Also known as: PRP, Autologous platelet-rich plasma, Autologous PRP

Platelet-rich plasma (PRP)

Saline DRUG

Also known as: 0.9% Sodium Chloride

Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients aged 18-50, inclusive.
• Healthy patients undergoing hip arthroscopy due to FAI.
• 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).
• No other influential disabilities in lower limbs, which could alter the post-operative therapy.
• No chronic use of NSAIDs, steroids, or chemotherapy drugs during the last 6 months before enrollment.
• 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.
• Intra-articular cartilage lesion grade 2-3-4-5 of Beck Classification or III-IV of Outerbridge.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver, CU Sports Medicine

Boulder, Colorado, 80304, United States

Location

MeSH Terms

Conditions

Femoracetabular Impingement; Fractures, Stress

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Cecilia Pascual-Garrido, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 28, 2018

Record last verified: 2018-12

Locations

US (1)