The primary objective of this study is the to prove that there is no difference in hip dislocation percentage to 8 weeks after total hip replacement in patient with or without the precepts of supine position when lying, in the first 8 weeks after…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters is the number of hip dislocation in the study
population.
Secondary outcome
The secondary study parameters are the quality of sleep, the level of
functional recovery, adherence, pain and client satisfaction assed by
questionnaires.
Background summary
In 2012, 592 primary total hip replacement were performed by the Orhopedisch
Centrum Oost Nederland. In the Netherlands 31.840 primary total hip replacement
are placed in 2009. One of the complications after a total hip replacement is
hip dislocation. Especially, in the first 8 weeks after the surgery there is a
risk for this complication. To reduces this risk patients receive during these
8 weeks precepts. In the Netherlands there is no consensus about these precepts
and the Nederlandse Orthopedische Vereniging (NOV) gives no advices. One of
these precepts is the supine position for 8 weeks after the surgery. It appears
that this precepts is experienced by patients as very stressful and the
adherence to this precepts decreases over time (Tijink, 2012).
For the replacement of a hip the OCON uses the posterolateral approach. No
literature is known about the added value of precepts after a total hip
replacement. However, for the anterolateral approach Peak et al., 2005
conducted a randomized clinical trial to precepts after surgery. The percentage
of hip dislocation in the total cohort was less than 1%. There were no
difference between with or without precepts concerning supine position.
Concerning the low risk of hip dislocation, the diversity of national advises
for precepts after surgery, the decrease of adherence over time and the burden
on the patient for supine position during sleep the OCON doubts the added value
of the precepts supine position after a total hip replacement.
Study objective
The primary objective of this study is the to prove that there is no difference
in hip dislocation percentage to 8 weeks after total hip replacement in patient
with or without the precepts of supine position when lying, in the first 8
weeks after surgery.
Study design
A blocked stratified surgeon blinded randomized clinical trial.
Intervention
patients in the intervention group will be exempted from sleeping on the back
during the first 8 weeks after total hip replacement surgery. The remaining
anti-luxation instructions (for example, bend forward) remain applicable.
Study burden and risks
This study is based on the hypothesis that there is no difference in percentage
of hip dislocations between groups with and without supine position as precept.
Participants are not burden with extra visits to the clinic. However,
participants are asked to fill out questionnaires pre-operative, 8 weeks
post-operative and 6 months post-operative. For the patient of the intervention
group there is the advantage of no precept concerning supine position during
the first 8 weeks after surgery.
Geerdinksweg 141
Hengelo 7555DL
NL
Geerdinksweg 141
Hengelo 7555DL
NL
Listed location countries
Age
Inclusion criteria
1. Placement of a primary total hip replacement via the posterolateral approach by hip orthopedic surgeons (Dr. Pakvis, Dr. Rompen Dr. Peters, Dr. Schuppers, Dr. van Doorn, dr. de Windt, dr. Buchholz, dr. Bergink, dr. Homan, dr. Oemar, dr. Wagenaar).
2. Patients with a ASA-classificatie of I or II.
Exclusion criteria
1. Blindness
2. replacement of 2nd total hip within six months after the 1st total hip replacement surgery
3. Insuffcient knowlegde of the Dutch language
4. Collumfracture
5. Infection of total hip replacement
6. Cognitive dysfunction
7. Already dependible of wheelchair
8. Hypermobility
9. Alcohol abuse
10. neurological disorders such as Parkinson and stroke
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL46706.044.13 |