Supine Sleeping After Total Hip Replacement

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

Full Title of Study: “The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2018

Detailed Description

stratified block randomized controlled trial

Interventions

  • Behavioral: Sleep position: no restrictions
    • during the first eight weeks after total hip replacement following a posterolateral surgical approach
  • Behavioral: Sleep position: supine
    • during the first eight weeks after total hip replacement following a posterolateral surgical approach

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage early hip dislocations
    • Time Frame: in first eight weeks after THP

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Orthopedisch Centrum Oost Nederland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anil Peters, Principal Investigator, Orthopedisch Centrum Oost Nederland

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