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Capsular closure versus unrepaired capsulotomy in hip arthroscopy


- candidate number24499
- NTR NumberNTR5903
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-jun-2016
- Secondary IDsP1562 
- Public TitleCapsular closure versus unrepaired capsulotomy in hip arthroscopy
- Scientific TitleCapsular closure versus unrepaired capsulotomy in hip arthroscopy
- ACRONYMCLOSE
- hypothesisPrimary hypothesis: Capsular repair results in less postoperative pain 12 weeks after surgery compared to capsulotomy in patients undergoing hip arthroscopy.
Secondary hypotheses: Capsular repair results in less postoperative pain at all other time points (1 to 12 weeks, and 52 weeks postoperatively) after surgery compared to capsulotomy in patients undergoing hip arthroscopy.
Capsular repair results in better Patient Reported Fu nctional Outcome Scores after surgery compared to capsulotomy in patients undergoing hip arthroscopy.
- Healt Condition(s) or Problem(s) studiedHip Replacement Arthroplasty, Femoroacetabular impingement (FAI)
- Inclusion criteriaAge between 18-65 years
Weight BMI < 35
Signed infomed consent
Intra-articular hip pathology suitable for hip arthroscopic surgery
Good understanding of Dutch/English language
- Exclusion criteriaRevision hip arthroscopy
Extra-articulair hip pathology
Documented systemic connective tissue disease
Prior hip surgery
Prior hip disease or fracture
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate1-aug-2017
- Target number of participants116
- InterventionsHip capsular closure versus unrepaired capsulotomy
- Primary outcomeNRS painscore system measured the first 12 weeks postopearatively
- Secondary outcomeHAGOS, iHOT 33 and Tegner activity scale are functional outcome scores.
These scores will be our secondary outcomes at 52 weeks follow up after surgery.
- TimepointsNRS pain score the first 12 weeks weekly

Functional outcome scores measured at 2,6,12 and 52 weeks postoperatively
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Niels. H. Bech
- CONTACT for SCIENTIFIC QUERIES Niels. H. Bech
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryHip arthroscopy is a becoming more and more popular procedure for hip pathology. So far it is unknown what the influence is of routine capsular closure after a procedure. This trial randomizes patients between capsular closure and unrepaired capsulotomy after hip arthroscopy.
Primary outcome is pain measured with the NRS the first 12 weeks after surgery.
Secondary outcome are functional outcome scores at 2,6,12 and 52 weeks after surgery.
- Main changes (audit trail)
- RECORD16-jun-2016 - 8-jul-2016


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