CREST: Capsular Repair During Hip Arthroscopy
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|ClinicalTrials.gov Identifier: NCT03372564|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hip Arthroscopy||Procedure: Hip Capsule Repair||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CREST: A Randomized Controlled Trial Comparing Inter-portal Hip Capsular Repair vs. No Repair Following Hip Arthroscopy|
|Actual Study Start Date :||November 7, 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Hip Capsule Repair
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.
Procedure: Hip Capsule Repair
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).
No Intervention: No Hip Capsule Repair (Control)
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.
- Hip Function [ Time Frame: Baseline, 6 months ]The main outcome assessed will be hip function including change in percentage of Hip outcome score (HOS score) from baseline to 6 month follow-up. The subscale of ADL (activities of daily living) and Sport will be utilized. each HOS subscale is calculated from 0 to 100%, with 100% being the best score.
- Hip ROM [ Time Frame: Baseline, 6 months ]Hip range of motion will be assessed by a blinded examiner. The change in degrees of range of motion from baseline to 6 month examination will be assessed.
- Pain [ Time Frame: Baseline, 6 months ]The change in pain scores will be assessed using VAS (visual analog scale) pain score, analyzing the change in units of measure between the baseline and 6 month time-points.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372564
|Contact: Jennifer Krogmanemail@example.com|
|United States, Arizona|
|Mayo Clinic in Arizona||Recruiting|
|Scottsdale, Arizona, United States, 85259|
|Contact: Jason Alben Alben.Jason@mayo.edu|
|Contact: Brynn Goldberg firstname.lastname@example.org|
|Principal Investigator: David Hartigan|
|United States, Illinois|
|American Hip Institute||Recruiting|
|Westmont, Illinois, United States, 60559|
|Contact: Joe Ornelas email@example.com|
|Principal Investigator: Benjamin Domb|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Jennifer Krogman 507-538-3562 firstname.lastname@example.org|
|Principal Investigator: Aaron J Krych|
|Principal Investigator:||Aaron J Krych||Mayo Clinic|