Femoroacetabular ImpingementNCT02183896
Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
A study testing Platelet-rich plasma (PRP) and Saline in people with Femoroacetabular Impingement and Chondral Lesions, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoroacetabular Impingement, Chondral Lesions
- What is being tested?
- Platelet-rich plasma (PRP) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver, CU Sports Medicine
Boulder, Colorado, 80304
About this study
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.
Read the 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.
- Conditions
- Femoroacetabular Impingement, Chondral Lesions
- Being tested
- Platelet-rich plasma (PRP), Saline
- Keywords
- Femoroacetabular impingement (FAI), Chondral lesions, Hip, Microfracture, Platelet-rich plasma (PRP)
- Medical subject headings
- Femoracetabular Impingement, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasma (PRP)Biological
Also called PRP, Autologous platelet-rich plasma, Autologous PRP
SalineDrug
Also called 0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI dGEMRIC
MRI dGEMRIC will be utilized to assess chondral healing. Change is being assessed between measurement time points.
Measured: 12 and 24 months post-operative
Secondary outcomes (7)
PA Hip X-Ray
Change is being assessed between measurement time points.
Measured: Baseline, 12 and 24 months post-operative
International Hip Outcome Tool (IHOT)
Patient reported outcomes assessed from patient completed surveys. Change is being assessed between measurement time points.
Measured: Pre-operative; and 3, 6, 12, and 24 month post-operative
Western Ontario and McMaster (WOMAC) osteoarthritis index
Patient reported outcomes assessed with patient completed survey.Change is being assessed between measurement time points.
Measured: Pre-operative; and 3, 6, 12, and 24 month post-operative
Non-arthritic hip score
Patient reported outcomes assessed with patient completed survey. Change is being assessed between measurement time points.
Measured: Pre-operative; and 3, 6, 12, and 24 month post-operative
Range of Motion (ROM)
ROM assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Measured: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
Flexion Abduction and External Rotation (FABER)
FABER assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Measured: 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
Bicycle kicks assessed as part of clinical outcome physical exam. Change is being assessed between measurement time points.
Measured: Pre-operative; prior to injections at week 1 and 2 post-operative; 6 week, and 3, 6, 12, and 24 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: PI left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Pascual-Garrido, M.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183896
- Sponsor's protocol ID
- 14-0080
- Status last verified
- Dec 2018
- First submitted
- 1 Jul 2014
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PRP (Platelet Rich Plasma) Following Arthroscopic Microfracture of Chondral Lesions of the Hip
- ClinicalTrials.gov ID
- NCT02183896
- Acronym / sponsor ID
- 14-0080
- Conditions
- Femoroacetabular Impingement, Chondral Lesions
- Keywords
- Femoroacetabular impingement (FAI), Chondral lesions, Hip, Microfracture, Platelet-rich plasma (PRP)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma (PRP) | Experimental | Biological: 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. |
| Saline | Placebo comparator | Drug: SalineIntra-articular injections in the hip of saline, solution week 1 and 2 post-operatively. Dose: 5 mL at each injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-rich plasma (PRP)Also: PRP, Autologous platelet-rich plasma, Autologous PRP | Biological | Platelet-rich plasma (PRP) |
| SalineAlso: 0.9% Sodium Chloride | Drug | Saline |
Primary outcome
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.
7 secondary outcomes
PA Hip X-Ray
Time frame: Baseline, 12 and 24 months post-operative
International Hip Outcome Tool (IHOT)
Time frame: Pre-operative; and 3, 6, 12, and 24 month post-operative
Western Ontario and McMaster (WOMAC) osteoarthritis index
Time frame: Pre-operative; and 3, 6, 12, and 24 month post-operative
Non-arthritic hip score
Time frame: Pre-operative; and 3, 6, 12, and 24 month post-operative
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Pascual-Garrido, M.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma (PRP) and Saline in people with Femoroacetabular Impingement and Chondral Lesions, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI dGEMRIC (time frame: 12 and 24 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.