Hip Dislocation, Osteoarthritis
Conditions
Keywords
Arthroplasty, Replacement, Hip, Posterolateral surgery, Precautions
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
Interventions
BEHAVIORALSleep position: no restrictions
during the first eight weeks after total hip replacement following a posterolateral surgical approach
BEHAVIORALSleep position: supine
during the first eight weeks after total hip replacement following a posterolateral surgical approach
Sponsors
Orthopedisch Centrum Oost Nederland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage early hip dislocations | in first eight weeks after THP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HOOS | eight weeks and six months post-operative | Hip Disability and Osteoarthritis Outcome Score |
| VHS | eight weeks and six months post-operative | Quality of Sleep |
| VAS/NRS hip | eight weeks and six months post-operative | pain intensity |
| Compliance anti-dislocation instructions | 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 |
| EQ-5D | eight weeks and six months post-operative | Quality of Life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleeping position preference | baseline | necessary information for the stratification procedure |
Countries
Netherlands
Outcome results
None listed