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| ID | Type | Description | Link |
|---|---|---|---|
| P13-31 METC Twente | Registry Identifier | Medical Ethical Committee Twente |
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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
stratified block randomized controlled trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep position: no restrictions | Behavioral | during the first eight weeks after total hip replacement following a posterolateral surgical approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage early hip dislocations | in first eight weeks after THP |
| Measure | Description | Time Frame |
|---|---|---|
| HOOS | Hip Disability and Osteoarthritis Outcome Score | eight weeks and six months post-operative |
| VHS | Quality of Sleep | eight weeks and six months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Sleeping position preference | necessary information for the stratification procedure | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Peters | Orthopedisch Centrum Oost Nederland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedisch Centrum Oost Nederland | Hengelo | Overijssel | 75550 AM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34932433 | Derived | 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. | |
| 26283079 |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Sleep position: supine | Behavioral | during the first eight weeks after total hip replacement following a posterolateral surgical approach |
|
| EQ-5D | Quality of Life | eight weeks and six months post-operative |
| VAS/NRS hip | pain intensity | eight weeks and six months post-operative |
| 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 |
| 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. |
| D004204 |
| Joint Dislocations |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |