Clinical Trial: Supine Sleeping After Total Hip Replacement

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: stratified block randomized controlled trial
Sponsor: Orthopedisch Centrum Oost Nederland

Current Primary Outcome: Percentage early hip dislocations [ Time Frame: in first eight weeks after THP ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• HOOS [ Time Frame: eight weeks and six months post-operative ]
  Hip Disability and Osteoarthritis Outcome Score
• VHS [ Time Frame: eight weeks and six months post-operative ]
  Quality of Sleep
• EQ-5D [ Time Frame: eight weeks and six months post-operative ]
  Quality of Life
• VAS/NRS hip [ Time Frame: eight weeks and six months post-operative ]
  pain intensity
• 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

Original Secondary Outcome: Same as current

Information By: Orthopedisch Centrum Oost Nederland

Dates:
Date Received: April 3, 2014
Date Started: June 2014
Date Completion: March 2020
Last Updated: April 18, 2017
Last Verified: November 2016