Supine Sleeping After Total Hip Replacement

Not Applicable

Completed

• Conditions: Osteoarthritis; Hip Dislocation

• Registration Number: NCT02107248
• Lead Sponsor: Orthopedisch Centrum Oost Nederland

Brief Summary

Aim of the current study is to test the non-inferiority hypothesis of differences in early hip dislocation between a group of patients who will be restricted to sleep in supine position and a group without restricted sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach

Detailed Description

stratified block randomized controlled trial

Study Timeline

• Study First Submitted: 2014-04-03
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Study Start: 2014-06
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

• Placement of a primary total hip replacement via the posterolateral approach by a high volume orthopaedic surgeon
• Patients with a ASA-classification of I or II

Exclusion Criteria

• Blindness
• Replacement of 2nd total hip within six months after the1st total hip replacement surgery
• Insufficient knowledge of the Dutch language
• Collum fracture
• Infection of total hip replacement
• Cognitive dysfunction
• Wheelchair dependability
• Hypermobility
• Alcohol abuse
• Neurological disorders such as Parkinson and stroke

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage early hip dislocations	in first eight weeks after THP

Secondary Outcome Measures

Name	Time	Method
EQ-5D	eight weeks and six months post-operative	Quality of Life
VAS/NRS hip	eight weeks and six months post-operative	pain intensity
Compliance anti-dislocation instructions	eight weeks post-operative	diary for patients to report their compliance with the set of anti-dislocation instructions, among which is the (daily) reporting of their sleeping position in bed at night
HOOS	eight weeks and six months post-operative	Hip Disability and Osteoarthritis Outcome Score
VHS	eight weeks and six months post-operative	Quality of Sleep

Trial Locations

Locations (1)

Orthopedisch Centrum Oost Nederland; 🇳🇱 Hengelo, Overijssel, Netherlands