Supine Sleeping After Total Hip Replacement

November 26, 2018 updated by: Orthopedisch Centrum Oost Nederland

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

stratified block randomized controlled trial

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Overijssel
      • Hengelo, Overijssel, Netherlands, 75550 AM
        • Orthopedisch Centrum Oost Nederland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Sleep position: supine
during the first eight weeks after 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
Behavioral: Sleep position: no restrictions
during the first eight weeks after total hip replacement following a posterolateral surgical approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleeping position preference
Time Frame: baseline
necessary information for the stratification procedure
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopedisch Centrum Oost Nederland

Investigators

  • Principal Investigator: Anil Peters, Orthopedisch Centrum Oost Nederland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL4670604413
  • P13-31 METC Twente (Registry Identifier: Medical Ethical Committee Twente)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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