Supine Sleeping After Total Hip Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Orthopedisch Centrum Oost Nederland
Sponsor:
Information provided by (Responsible Party):
Orthopedisch Centrum Oost Nederland
ClinicalTrials.gov Identifier:
NCT02107248
First received: April 3, 2014
Last updated: June 16, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HOOS [ Time Frame: eight weeks and six months post-operative ] [ Designated as safety issue: No ]
    Hip Disability and Osteoarthritis Outcome Score

  • VHS [ Time Frame: eight weeks and six months post-operative ] [ Designated as safety issue: No ]
    Quality of Sleep

  • EQ-5D [ Time Frame: eight weeks and six months post-operative ] [ Designated as safety issue: No ]
    Quality of Life

  • VAS/NRS hip [ Time Frame: eight weeks and six months post-operative ] [ Designated as safety issue: No ]
    pain intensity

  • Compliance anti-dislocation instructions [ Time Frame: eight weeks post-operative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    necessary information for the stratification procedure


Estimated Enrollment: 456
Study Start Date: June 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (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

Genders Eligible for Study:   Both
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

Contacts
Contact: Anil Peters a.peters2@zgt.nl

Locations
Netherlands
Orthopedisch Centrum Oost Nederland Recruiting
Hengelo, Overijssel, Netherlands, 75550 AM
Sub-Investigator: Rianne Huis in 't Veld, PhD         
Principal Investigator: Anil Peters, MD         
Sponsors and Collaborators
Orthopedisch Centrum Oost Nederland
Investigators
Principal Investigator: Anil Peters Orthopedisch Centrum Oost Nederland
  More Information

No publications provided

Responsible Party: Orthopedisch Centrum Oost Nederland
ClinicalTrials.gov Identifier: NCT02107248     History of Changes
Other Study ID Numbers: NL4670604413, P13-31 METC Twente
Study First Received: April 3, 2014
Last Updated: June 16, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on July 26, 2014