Supine Sleeping After Total Hip Replacement

Orthopedisch Centrum Oost Nederland456 enrolled

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

stratified block randomized controlled trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

456

Conditions

Osteoarthritis Hip Dislocation

Interventions

Sleep position: no restrictionsBEHAVIORAL

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

Sleep position: supineBEHAVIORAL

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Orthopedisch Centrum Oost Nederland

Hengelo, Overijssel, Netherlands

Outcomes

Primary Outcomes

Percentage early hip dislocations

Time frame: in first eight weeks after THP

Secondary Outcomes

HOOS

Hip Disability and Osteoarthritis Outcome Score

Time frame: eight weeks and six months post-operative

VHS

Quality of Sleep

Time frame: eight weeks and six months post-operative

EQ-5D

Quality of Life

Time frame: eight weeks and six months post-operative

VAS/NRS hip

pain intensity

Time frame: 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

Time frame: eight weeks post-operative

Data from ClinicalTrials.gov

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