Back to resultsEfficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
Primary Purpose
Femoroacetabular Impingement, Chondral Lesions
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet-rich plasma (PRP)
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Femoroacetabular Impingement focused on measuring Femoroacetabular impingement (FAI), Chondral lesions, Hip, Microfracture, Platelet-rich plasma (PRP)
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Non-adherence according to inclusion criteria.
- Patients allergic to lidocaine
Sites / Locations
- University of Colorado Denver, CU Sports Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Platelet-rich plasma (PRP)
Saline
Arm Description
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.
Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.
Outcomes
Primary Outcome Measures
MRI dGEMRIC
MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.
Secondary Outcome Measures
PA Hip X-Ray
Change is being assessed between measurement time points.
International Hip Outcome Tool (IHOT)
Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.
Western Ontario and McMaster (WOMAC) osteoarthritis index
Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.
Non-arthritic hip score
Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.
Range of Motion (ROM)
ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Flexion Abduction and External Rotation (FABER)
FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Bicycle Kicks
Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Full Information
NCT ID
NCT02183896
First Posted
July 1, 2014
Last Updated
December 26, 2018
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02183896
Brief Title
Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
Official Title
Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI left
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Evaluate clinical efficacy of intra-articular injections of platelet-rich plasma (PRP) following arthroscopic microfracture.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement, Chondral Lesions
Keywords
Femoroacetabular impingement (FAI), Chondral lesions, Hip, Microfracture, Platelet-rich plasma (PRP)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet-rich plasma (PRP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
Intra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection.
Intervention Type
Biological
Intervention Name(s)
Platelet-rich plasma (PRP)
Other Intervention Name(s)
PRP, Autologous platelet-rich plasma, Autologous PRP
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
0.9% Sodium Chloride
Primary Outcome Measure Information:
Title
MRI dGEMRIC
Description
MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.
Time Frame
12 and 24 months post-operative
Secondary Outcome Measure Information:
Title
PA Hip X-Ray
Description
Change is being assessed between measurement time points.
Time Frame
Baseline, 12 and 24 months post-operative
Title
International Hip Outcome Tool (IHOT)
Description
Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.
Time Frame
Pre-operative; and 3, 6, 12, and 24 month post-operative
Title
Western Ontario and McMaster (WOMAC) osteoarthritis index
Description
Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.
Time Frame
Pre-operative; and 3, 6, 12, and 24 month post-operative
Title
Non-arthritic hip score
Description
Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.
Time Frame
Pre-operative; and 3, 6, 12, and 24 month post-operative
Title
Range of Motion (ROM)
Description
ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
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
Title
Flexion Abduction and External Rotation (FABER)
Description
FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
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
Title
Bicycle Kicks
Description
Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Non-adherence according to inclusion criteria.
Patients allergic to lidocaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Pascual-Garrido, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver, CU Sports Medicine
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
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