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Hip Capsule Repair for Hip Pain
N/A
Waitlist Available
Led By Aaron J Krych
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
FAI documented on X-Ray or Magnetic resonance imaging (MRI) or magnetic resonance arthrogram (MRA)
Intraoperative labral repair or intact labrum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
Study Summary
This trial is testing whether or not repairing the hip joint capsule (a ligament) will improve function and quality of life for people with hip pain.
Who is the study for?
The CREST trial is for adults aged 18 to 50 with hip pain lasting over three months that hasn't improved with non-surgical treatments. Participants must have FAI confirmed by imaging, an intact labrum or one repaired during surgery, and be able to understand and speak English.Check my eligibility
What is being tested?
This study tests if repairing the hip capsule during arthroscopy improves function. It involves 240 patients split into two groups, comparing outcomes like hip motion and satisfaction at six months post-surgery using a blinded approach.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks of hip arthroscopy may include discomfort at the incision site, temporary numbness or tingling due to anesthesia, joint stiffness, bruising around the hip area, and less commonly infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My hip issue is confirmed by an X-Ray, MRI, or MRA.
Select...
I have had surgery to fix or have an intact shoulder labrum.
Select...
I am between 18 and 50 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hip Function
Secondary outcome measures
Hip ROM
Visual Analog Pain Score Progression
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hip Capsule RepairExperimental Treatment1 Intervention
Patients in the intervention group (Hip capsule repair) will undergo initial diagnostic arthroscopy of the hip. Two to three standard portals (anterolateral, mid anterior, distal antero-lateral, posterolateral) will be used during the entire procedure to assess and treat the patient. After establishing standard portals, an interportal capsulotomy is completed to allow for complete evaluation of the central compartment of the hip. In the central compartment, significant and obvious pathologies will be addressed accordingly. Following addressing central compartment pathologies, cam impingement type lesions in the peripheral compartment will be treated. Once all pathologies are addressed, the interportal capsulotomy10 will be repaired by using simple interrupted sutures with absorbable suture (Number 1 Vicryl). Three to four simples sutures will be placed and tied using arthroscopic technique.
Group II: No Hip Capsule Repair (Control)Active Control1 Intervention
Patients in the control group (no hip capsule repair) have the same portals utilized and will have the same interportal capsulotomy performed. They will have all central and peripheral compartment pathologies addressed in the same way that the study group does. At the conclusion of the case, the hip capsule will be left open and not repaired.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,208 Previous Clinical Trials
3,766,800 Total Patients Enrolled
1 Trials studying Hip Arthroscopy
188 Patients Enrolled for Hip Arthroscopy
Aaron J KrychPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hip issue is confirmed by an X-Ray, MRI, or MRA.I have an inflammatory or autoimmune disease.I have serious health issues like uncontrolled diabetes or heart problems.My joints are very flexible, moving more than 2 cm under pressure.I have had hip pain for over 3 months and treatments like physical therapy or painkillers haven't helped.I have had surgery to fix or have an intact shoulder labrum.I am taking medication to suppress my immune system.I am undergoing additional procedures like MFX and iliopsoas lengthening.I have had surgery to clean up the labrum in my hip or shoulder.I have had surgery to repair or clean up the labrum in my hip or shoulder.You have a condition called hypermobility/Ehlers-Danlos syndrome.I need help with daily activities due to a severe disability.I am between 18 and 50 years old.I have been diagnosed with avascular necrosis.I had a surgery that changed my rehab plan.I have severe hip arthritis.I have had surgery or an injury to my hip before.I have severe hip socket deformities.I am scheduled for or have had hip or deep buttock area surgery.I had surgery as a child for a hip condition.I am scheduled for or have had labral reconstruction surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Hip Capsule Repair
- Group 2: No Hip Capsule Repair (Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age range for this research trial limited to individuals aged 35 and under?
"According to the prerequisites for this clinical trial, individuals between 18 and 50 years old are eligible."
Answered by AI
How can I participate in this medical research?
"Requisites for acceptance into this medical trial include arthroscopy and an age range between 18 to 50 years old. The research is aiming to recruit a cohort of 240 volunteers."
Answered by AI
How many individuals have been enrolled in this clinical trial thus far?
"This medical trial necessitates 240 eligible participants from multiple sites including Mayo Clinic in Arizona, Scottsdale and the Rochester branch of Mayo Clinic."
Answered by AI
Are patients currently being enrolled in this trial?
"Affirmative. As per information listed on clinicaltrials.gov, the medical trial is actively recruiting for 240 participants at 3 sites. It was initially posted November 7th 2017 and last updated December 23rd 2021."
Answered by AI
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