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Supine Sleeping After Total Hip Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Orthopedisch Centrum Oost Nederland
ClinicalTrials.gov Identifier:
NCT02107248
First received: April 3, 2014
Last updated: April 18, 2017
Last verified: November 2016
  Purpose
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

Condition Intervention
Osteoarthritis Hip Dislocation Behavioral: Sleep position: no restrictions Behavioral: Sleep position: supine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation

Resource links provided by NLM:


Further study details as provided by Orthopedisch Centrum Oost Nederland:

Primary Outcome Measures:
  • Percentage early hip dislocations [ Time Frame: in first eight weeks after THP ]

Secondary Outcome 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


Other Outcome Measures:
  • Sleeping position preference [ Time Frame: baseline ]
    necessary information for the stratification procedure


Enrollment: 456
Study Start Date: June 2014
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
stratified block randomized controlled trial
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02107248

Locations
Netherlands
Orthopedisch Centrum Oost Nederland
Hengelo, Overijssel, Netherlands, 75550 AM
Sponsors and Collaborators
Orthopedisch Centrum Oost Nederland
Investigators
Principal Investigator: Anil Peters Orthopedisch Centrum Oost Nederland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orthopedisch Centrum Oost Nederland
ClinicalTrials.gov Identifier: NCT02107248     History of Changes
Other Study ID Numbers: NL4670604413
P13-31 METC Twente ( Registry Identifier: Medical Ethical Committee Twente )
Study First Received: April 3, 2014
Last Updated: April 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Orthopedisch Centrum Oost Nederland:
Arthroplasty
Replacement
Hip
Posterolateral surgery
Precautions

Additional relevant MeSH terms:
Osteoarthritis
Dislocations
Hip Dislocation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries
Hip Injuries

ClinicalTrials.gov processed this record on July 27, 2017