The aim of this study is to examine whether a joint-specific educational module (preoperative education about the recovery of symptoms, physical functioning and psychological well-being (index group)) will improve patient satisfaction after TKA…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will be patient satisfaction with the 12 months
results of TKA.
Secondary outcome
The secondary outcome measures will be change in clinical outcome scores 3 and
12 months after TKA procedure and change in patient expectations at the day of
admission compared to baseline.
Background summary
Despite the fact joint replacement of the knee is a very successful surgical
intervention for patients with end-stage osteoarthritis, a subgroup of the
patients is not satisfied with the final results. One of the main modifiable
factors that are related to patient satisfaction is whether the expectations of
the patients are fulfilled. Frequently a discrepancy exists between
expectations of the patients and those of the surgeon regarding the outcome of
a total knee replacement (TKA). It seems that surgeons have more realistic
expectations regarding relief of pain, improvement in physical functioning and
improvement in psychosocial well-being. Specific information about these topics
could lead to more realistic patient expectations. The current preoperative
information giving is predominantly focused on the process of care and the
immediately postoperative period. This can be extended by giving preoperative
education about the recovery of symptoms, physical functioning and
psychological well-being.
In this randomised clinical trial 204 patients indicated for a TKA will be
included and will be prospectively evaluated for 1 year.
Study objective
The aim of this study is to examine whether a joint-specific educational module
(preoperative education about the recovery of symptoms, physical functioning
and psychological well-being (index group)) will improve patient satisfaction
after TKA compared to usual information giving (control group).
The hypothesis is that a preoperative joint-specific educational module is more
effective to increase the satisfaction rate of patients undergoing a joint
replacement of the knee compared to the usual given information (superiority
study).
Study design
a double-blinded randomized clinical trial.
Intervention
Patients will be randomized in a) a joint-specific educational module
(preoperative education about the recovery of symptoms, physical functioning
and psychological well-being (index group) or in b) the usual given
information.
Study burden and risks
The burden is primarily time (extra time consumed by the education module in
the intervention group and time to fill out questionnaires).
ds. Th Fliednerstraat 1
Eindhoven 5631 BM
NL
ds. Th Fliednerstraat 1
Eindhoven 5631 BM
NL
Listed location countries
Age
Inclusion criteria
Symptomatic and radiographic knee OA indicated for a primary TKA
Exclusion criteria
- Presence of a medical illness that result in a life expectancy shorter than 1 year,
- Presence of TKA of the contra lateral side
- Insufficient command of the Dutch language
- Legally incompetent adults
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54671.015.15 |
| OMON | NL-OMON25479 |