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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

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

NCT ID

NCT02107248

First Posted

April 3, 2014

Last Updated

November 26, 2018

Sponsor

Orthopedisch Centrum Oost Nederland

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

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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