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The influence of Expectation modification in Knee arthroplasty on Satisfaction of PatiEnts, a randomized Controlled Trial


- candidate number24124
- NTR NumberNTR5779
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mrt-2016
- Secondary IDsNL54671.015.15 CCMO
- Public TitleThe influence of Expectation modification in Knee arthroplasty on Satisfaction of PatiEnts, a randomized Controlled Trial
- Scientific TitleThe influence of Expectation modification in Knee arthroplasty on Satisfaction of PatiEnts, a randomized Controlled Trial
- ACRONYMThe EKSPECT study
- hypothesisA 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
- Healt Condition(s) or Problem(s) studiedKnee osteoarhritis, Gonarthrose
- Inclusion criteriaSymptomatic and radiographic knee OA indicated for a primary TKA
- Exclusion criteriaPresence of a medical illness that result in a Life expectancy shorter than 1 year.
Presence of TKA of the contralateral side.
Insufficient command of the Dutch language.
Legally incompetent adults.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2016
- planned closingdate
- Target number of participants204
- InterventionsPatients 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.
- Primary outcomePatient satisfaction one year postoperative.
- Secondary outcome- To assess whether there is an effect on patient expectations concerning the results of TKA of a preoperative joint-specific educational module (intervention) compared to the usual information giving (control).
- Explorative analysis will be performed to assess whether the preoperative joint-specific education is more effective in subgroups of patients.
- TimepointsPre-operative, 3 months and 1 year postoperative
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES J.J. Tolk
- CONTACT for SCIENTIFIC QUERIES J.J. Tolk
- Sponsor/Initiator Máxima Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- Publications
- Brief summaryRationale: 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.

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.

Study population: Patients visiting an orthopaedic surgeon at the outpatient clinic of Máxima Medical Centre, with clinical and radiological knee osteoarthritis, indicated and planned for a TKA are eligible for this study.

Intervention (if applicable): 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.

Main study parameters/endpoints: The primary outcome measure will be patient satisfaction with the 12 months results of TKA.
- Main changes (audit trail)
- RECORD17-mrt-2016 - 25-mei-2016


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