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Supine Sleeping After Total Hip Replacement

Primary Purpose

Osteoarthritis, Hip Dislocation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Sleep position: no restrictions
Sleep position: supine
Sponsored by
Orthopedisch Centrum Oost Nederland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthroplasty, Replacement, Hip, Posterolateral surgery, Precautions

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Orthopedisch Centrum Oost Nederland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sleep position: supine

Sleep position: no restrictions

Arm 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

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

Outcomes

Primary Outcome Measures

Percentage early hip dislocations

Secondary Outcome Measures

HOOS
Hip Disability and Osteoarthritis Outcome Score
VHS
Quality of Sleep
EQ-5D
Quality of Life
VAS/NRS hip
pain intensity
Compliance anti-dislocation instructions
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

Full Information

First Posted
April 3, 2014
Last Updated
November 26, 2018
Sponsor
Orthopedisch Centrum Oost Nederland
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1. Study Identification

Unique Protocol Identification Number
NCT02107248
Brief Title
Supine Sleeping After Total Hip Replacement
Official Title
The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopedisch Centrum Oost Nederland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
stratified block randomized controlled trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip Dislocation
Keywords
Arthroplasty, Replacement, Hip, Posterolateral surgery, Precautions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
456 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep position: supine
Arm Type
Active Comparator
Arm 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
Arm Title
Sleep position: no restrictions
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Sleep position: no restrictions
Intervention Description
during the first eight weeks after total hip replacement following a posterolateral surgical approach
Intervention Type
Behavioral
Intervention Name(s)
Sleep position: supine
Intervention Description
during the first eight weeks after total hip replacement following a posterolateral surgical approach
Primary Outcome Measure Information:
Title
Percentage early hip dislocations
Time Frame
in first eight weeks after THP
Secondary Outcome Measure Information:
Title
HOOS
Description
Hip Disability and Osteoarthritis Outcome Score
Time Frame
eight weeks and six months post-operative
Title
VHS
Description
Quality of Sleep
Time Frame
eight weeks and six months post-operative
Title
EQ-5D
Description
Quality of Life
Time Frame
eight weeks and six months post-operative
Title
VAS/NRS hip
Description
pain intensity
Time Frame
eight weeks and six months post-operative
Title
Compliance anti-dislocation instructions
Description
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
Time Frame
eight weeks post-operative
Other Pre-specified Outcome Measures:
Title
Sleeping position preference
Description
necessary information for the stratification procedure
Time Frame
baseline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anil Peters
Organizational Affiliation
Orthopedisch Centrum Oost Nederland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedisch Centrum Oost Nederland
City
Hengelo
State/Province
Overijssel
ZIP/Postal Code
75550 AM
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34932433
Citation
Peters A, Manning F, Tijink M, Vollenbroek-Hutten M, Huis In 't Veld R. Patient compliance with postoperative precautions in an unrestricted and a supine sleeping position following posterolateral total hip arthroplasty: a randomized controlled trial. Disabil Rehabil. 2022 Dec;44(26):8303-8310. doi: 10.1080/09638288.2021.2012606. Epub 2021 Dec 21.
Results Reference
derived
PubMed Identifier
26283079
Citation
Peters A, Tijink M, Veldhuijzen A, Huis in 't Veld R. Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial. Trials. 2015 Aug 18;16:360. doi: 10.1186/s13063-015-0901-0.
Results Reference
derived

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Supine Sleeping After Total Hip Replacement

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