Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02183896
Recruitment Status : Withdrawn (PI left)
First Posted : July 8, 2014
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE July 1, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date December 28, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
MRI dGEMRIC [ Time Frame: 12 and 24 months post-operative ]
MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • PA Hip X-Ray [ Time Frame: Baseline, 12 and 24 months post-operative ]
    Change is being assessed between measurement time points.
  • International Hip Outcome Tool (IHOT) [ Time Frame: Pre-operative; and 3, 6, 12, and 24 month post-operative ]
    Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.
  • Western Ontario and McMaster (WOMAC) osteoarthritis index [ Time Frame: Pre-operative; and 3, 6, 12, and 24 month post-operative ]
    Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.
  • Non-arthritic hip score [ Time Frame: Pre-operative; and 3, 6, 12, and 24 month post-operative ]
    Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.
  • Range of Motion (ROM) [ Time Frame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative ]
    ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
  • Flexion Abduction and External Rotation (FABER) [ Time Frame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative ]
    FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
  • Bicycle Kicks [ Time Frame: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative ]
    Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
Official Title  ICMJE Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Femoroacetabular Impingement
  • Chondral Lesions
Intervention  ICMJE
  • Biological: Platelet-rich plasma (PRP)
    Other Names:
    • PRP
    • Autologous platelet-rich plasma
    • Autologous PRP
  • Drug: Saline
    Other Name: 0.9% Sodium Chloride
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Biological: Platelet-rich plasma (PRP)
  • Placebo Comparator: Saline
    Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 26, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
30
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02183896
Other Study ID Numbers  ICMJE 14-0080
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cecilia Pascual-Garrido, M.D. University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP