Supine Sleeping After Total Hip Replacement

Osteoarthritis Clinical Trial

Official title:

The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107248
• Other study ID #: NL4670604413
• Secondary ID: P13-31 METC Twen
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: March 2018

Study information

• Verified date: November 2018
• Source: Orthopedisch Centrum Oost Nederland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

stratified block randomized controlled trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Dislocation
• Osteoarthritis

Intervention

Behavioral:
• Sleep position: no restrictions
during the first eight weeks after total hip replacement following a posterolateral surgical approach
• Sleep position: supine
during the first eight weeks after total hip replacement following a posterolateral surgical approach

Locations

Country	Name	City	State
Netherlands	Orthopedisch Centrum Oost Nederland	Hengelo	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Orthopedisch Centrum Oost Nederland

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleeping position preference	necessary information for the stratification procedure	baseline
Primary	Percentage early hip dislocations		in first eight weeks after THP
Secondary	HOOS	Hip Disability and Osteoarthritis Outcome Score	eight weeks and six months post-operative
Secondary	VHS	Quality of Sleep	eight weeks and six months post-operative
Secondary	EQ-5D	Quality of Life	eight weeks and six months post-operative
Secondary	VAS/NRS hip	pain intensity	eight weeks and six months post-operative
Secondary	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	eight weeks post-operative