Supine Sleeping After Total Hip Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-03-31

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

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Detailed Description

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stratified block randomized controlled trial

Conditions

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Osteoarthritis Hip Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Sleep position: supine

Intervention Type BEHAVIORAL

during the first eight weeks after total hip replacement following a posterolateral surgical approach

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

Group Type EXPERIMENTAL

Sleep position: no restrictions

Intervention Type BEHAVIORAL

during the first eight weeks after total hip replacement following a posterolateral surgical approach

Interventions

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Sleep position: no restrictions

during the first eight weeks after total hip replacement following a posterolateral surgical approach

Intervention Type BEHAVIORAL

Sleep position: supine

during the first eight weeks after total hip replacement following a posterolateral surgical approach

Intervention Type BEHAVIORAL

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No