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OpenTrials
Completed

NCT Number: NCT02107248

Supine Sleeping After Total Hip Replacement

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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Key information

Conditions

Osteoarthritis Arthritis Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Rheumatic Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedisch Centrum Oost Nederland

Hengelo, Overijssel, 75550 AM, Netherlands

About this study

stratified block randomized controlled trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep position: no restrictions

Behavioral

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

Sleep position: supine

Behavioral

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

Primary outcomes

  1. Percentage early hip dislocations

    Time frame: in first eight weeks after THP

Secondary outcomes

  1. HOOS

    Time frame: eight weeks and six months post-operative

    Hip Disability and Osteoarthritis Outcome Score

  2. VHS

    Time frame: eight weeks and six months post-operative

    Quality of Sleep

  3. EQ-5D

    Time frame: eight weeks and six months post-operative

    Quality of Life

  4. VAS/NRS hip

    Time frame: eight weeks and six months post-operative

    pain intensity

  5. 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

Other outcomes

  1. Sleeping position preference

    Time frame: baseline

    necessary information for the stratification procedure

Sponsors and collaborators

Lead sponsor

Orthopedisch Centrum Oost Nederland

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2014
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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