Supine Sleeping After Total Hip Replacement
Overview
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
Full Title of Study: “The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: March 2018
Detailed Description
stratified block randomized controlled trial
Interventions
- Behavioral: Sleep position: no restrictions
- during the first eight weeks after total hip replacement following a posterolateral surgical approach
- Behavioral: Sleep position: supine
- during the first eight weeks after total hip replacement following a posterolateral surgical approach
Arms, Groups and Cohorts
- Active Comparator: Sleep position: supine
- Subjects will be instructed to sleep in a supine position during the first eight weeks after a total hip replacement following a posterolateral surgical approach
- Experimental: Sleep position: no restrictions
- Patients do not have any restrictions in sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach
Clinical Trial Outcome Measures
Primary Measures
- Percentage early hip dislocations
- Time Frame: in first eight weeks after THP
Secondary Measures
- HOOS
- Time Frame: eight weeks and six months post-operative
- Hip Disability and Osteoarthritis Outcome Score
- VHS
- Time Frame: eight weeks and six months post-operative
- Quality of Sleep
- EQ-5D
- Time Frame: eight weeks and six months post-operative
- Quality of Life
- VAS/NRS hip
- Time Frame: eight weeks and six months post-operative
- pain intensity
- Compliance anti-dislocation instructions
- Time Frame: 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Orthopedisch Centrum Oost Nederland
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Anil Peters, Principal Investigator, Orthopedisch Centrum Oost Nederland
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