OsteoarthritisNCT02107248
Supine Sleeping After Total Hip Replacement
A study testing Sleep position: no restrictions and Sleep position: supine in people with Osteoarthritis and Hip Dislocation, run by Orthopedisch Centrum Oost Nederland at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Hip Dislocation
- What is being tested?
- Sleep position: no restrictions and Sleep position: supine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Wheelchair dependability
- Hypermobility
- Alcohol abuse
- Neurological disorders such as Parkinson and stroke
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Orthopedisch Centrum Oost Nederland
Hengelo, Overijssel, 75550 AM
About this study
Official title: The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation
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
Read the detailed description
stratified block randomized controlled trial
- Conditions
- Osteoarthritis, Hip Dislocation
- Being tested
- Sleep position: no restrictions, Sleep position: supine
- Keywords
- Arthroplasty, Replacement, Hip, Posterolateral surgery, Precautions
- Medical subject headings
- Osteoarthritis, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep position: no restrictionsBehavioural
during the first eight weeks after total hip replacement following a posterolateral surgical approach
Sleep position: supineBehavioural
during the first eight weeks after total hip replacement following a posterolateral surgical approach
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Sleep position: supine |
| 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 Receives: Behavioral: Sleep position: no restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage early hip dislocations
Measured: in first eight weeks after THP
Secondary outcomes (5)
HOOS
Hip Disability and Osteoarthritis Outcome Score
Measured: eight weeks and six months post-operative
VHS
Quality of Sleep
Measured: eight weeks and six months post-operative
EQ-5D
Quality of Life
Measured: eight weeks and six months post-operative
VAS/NRS hip
pain intensity
Measured: 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
Measured: eight weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedisch Centrum Oost Nederland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil Peters, Principal investigator, Orthopedisch Centrum Oost Nederland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107248
- Sponsor's protocol ID
- NL4670604413
- Other IDs
- P13-31 METC Twente
- Status last verified
- Nov 2018
- First submitted
- 3 Apr 2014
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34932433Peters 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.
PubMed 26283079
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Need for Supine Position Advise During Sleep in the First 8 Week After a Total Hip Replacement to Prevent Hip Dislocation
- ClinicalTrials.gov ID
- NCT02107248
- Acronym / sponsor ID
- NL4670604413
- Conditions
- Osteoarthritis, Hip Dislocation
- Keywords
- Arthroplasty, Replacement, Hip, Posterolateral surgery, Precautions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Orthopedisch Centrum Oost NederlandUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep position: supine | Active comparator | Behavioral: Sleep position: supineSubjects 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 | Behavioral: Sleep position: no restrictionsPatients do not have any restrictions in sleeping position during the first eight weeks after a total hip replacement following a posterolateral surgical approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep position: no restrictionsduring the first eight weeks after total hip replacement following a posterolateral surgical approach | Behavioural | Sleep position: no restrictions |
| Sleep position: supineduring the first eight weeks after total hip replacement following a posterolateral surgical approach | Behavioural | Sleep position: supine |
Primary outcome
Percentage early hip dislocations
Time frame: in first eight weeks after THP
5 secondary outcomes
HOOS
Time frame: eight weeks and six months post-operative
VHS
Time frame: eight weeks and six months post-operative
EQ-5D
Time frame: eight weeks and six months post-operative
VAS/NRS hip
Time frame: eight weeks and six months post-operative
Compliance anti-dislocation instructions
Time frame: eight weeks post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 34932433Peters 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.
- Derived from this study: PubMed 26283079Peters 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Peters principal investigator
Orthopedisch Centrum Oost Nederland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep position: no restrictions and Sleep position: supine in people with Osteoarthritis and Hip Dislocation, run by Orthopedisch Centrum Oost Nederland at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage early hip dislocations (time frame: in first eight weeks after THP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02107248, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.