NCT02107248

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
456

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

3.8 years

First QC Date

April 3, 2014

Last Update Submit

November 26, 2018

Conditions

OsteoarthritisHip Dislocation

Keywords

ArthroplastyReplacementHipPosterolateral surgeryPrecautions

Outcome Measures

Primary Outcomes (1)

  • Percentage early hip dislocations

    in first eight weeks after THP

Secondary Outcomes (5)

  • HOOS

    eight weeks and six months post-operative

  • VHS

    eight weeks and six months post-operative

  • EQ-5D

    eight weeks and six months post-operative

  • VAS/NRS hip

    eight weeks and six months post-operative

  • Compliance anti-dislocation instructions

    eight weeks post-operative

Other Outcomes (1)

  • Sleeping position preference

    baseline

Study Arms (2)

Sleep position: supine

ACTIVE COMPARATOR

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

Sleep position: no restrictions

EXPERIMENTAL

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

Interventions

Sleep position: no restrictionsBEHAVIORAL

during the first eight weeks after total hip replacement following a posterolateral surgical approach

Sleep position: no restrictions
Sleep position: supineBEHAVIORAL

during the first eight weeks after total hip replacement following a posterolateral surgical approach

Sleep position: supine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedisch Centrum Oost Nederland

Hengelo, Overijssel, 75550 AM, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 34932433DERIVED

  • 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.

    PMID: 26283079DERIVED

MeSH Terms

Conditions

OsteoarthritisHip Dislocation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesJoint DislocationsWounds and InjuriesHip Injuries

Study Officials

  • Anil Peters

    Orthopedisch Centrum Oost Nederland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 8, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

NL(1)