Supine Sleeping After Total Hip Replacement

Study Overview
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Brief Summary
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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
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stratified block randomized controlled trial

Official Title
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The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation

Conditions
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Osteoarthritis, Hip Dislocation

Intervention / Treatment
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* Behavioral: Sleep position: no restrictions
* Behavioral: Sleep position: supine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep position: supine<br>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 | Behavioral: Sleep position: supine<br>* during the first eight weeks after total hip replacement following a posterolateral surgical approach<br>|
| Experimental: Sleep position: no restrictions<br>Patients do not have any restrictions in sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach | Behavioral: Sleep position: no restrictions<br>* during the first eight weeks after total hip replacement following a posterolateral surgical approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage early hip dislocations |  | in first eight weeks after THP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOOS | Hip Disability and Osteoarthritis Outcome Score | eight weeks and six months post-operative | 
| VHS | Quality of Sleep | eight weeks and six months post-operative | 
| EQ-5D | Quality of Life | eight weeks and six months post-operative | 
| VAS/NRS hip | pain intensity | eight weeks and six months post-operative | 
| Compliance anti-dislocation instructions | 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 | eight weeks post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip, Arthroplasty, Replacement, Posterolateral surgery, Precautions