Supine Sleeping After Total Hip Replacement

Orthopedisch Centrum Oost Nederland

Status: Completed

Conditions: Hip Dislocation; Osteoarthritis

Treatments: Behavioral: Sleep position: supine; Behavioral: Sleep position: no restrictions

Study type: Interventional

Funder types: Other

Identifiers

NCT02107248

P13-31 METC Twente (Registry Identifier)

NL4670604413

Details and patient eligibility

About

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 description

stratified block randomized controlled trial

Enrollment: 456 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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456 participants in 2 patient groups

Sleep position: supine

Active Comparator group

Description:

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

Treatment:

Behavioral: Sleep position: supine

Sleep position: no restrictions

Experimental group

Description:

Patients do not have any restrictions in sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach

Treatment:

Behavioral: Sleep position: no restrictions