To evaluate the cost-effectiveness of optimized, treat-to-target PPT in TKA/THA patients as compared to usual PPT. Thehypothesis is that with the optimized strategy superior functional outcomes can be achieved compared to usual care, at lowercosts (…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between both groups regarding changes of KOOS-PS/HOOS-PS, a measure
of physical functioning, between
baseline and 3 months postoperatively.
Differences between both groups regarding cost-effectiveness.
Secondary outcome
Differences between both groups in:
- recovery of function during 12 months follow-up,
- in scores of OKS/OHS (functioning), NRS (amount of pain), EQ-5D (quality of
life), performance tests, physical activity level, and satisfaction of the
patient.
Background summary
Postoperative physiotherapy (PPT) is a proven effective treatment after total
knee (TKA) and hip arthroplasty (THA), however
research shows that there is no consensus regarding its timing, content and
duration and practice variation is considerable. We
propose an evaluation of optimized, personalized treat-to-target PPT, which is
presented in the form of a transmural care
pathway.
Study objective
To evaluate the cost-effectiveness of optimized, treat-to-target PPT in TKA/THA
patients as compared to usual PPT. The
hypothesis is that with the optimized strategy superior functional outcomes can
be achieved compared to usual care, at lower
costs (superiority study).
Study design
Cluster randomized study
Intervention
Treat-to-target: optimized, personalized strategy implying that after receiving
PT in the postoperative phase in the hospital will
either or not be referred to primary care PT based on a standardized assessment
of their health status, personal-, external
factors and achievement of functional milestones. Those needing PPT in primary
care receive a standardized, time contingent
program, focused on evidence-based components muscle strengthening and
functional exercises, with regular evaluations
regarding achievement of functional milestones. After reaching the milestones,
PPT is ended and patients will receive a
tailored advice with home-based exercises in combination with referral to
exercise activities in the community. The
treat-to-target PPT is based on scientific evidence and expert opinion and is
presented in the form of a transmural care
pathway.
Usual care: Current PPT delivery
Study burden and risks
Patients will be asked to fill out questionnaires at 6 time points (at home,
web-based program). At three time points the patients will be asked to perform
physical performance tests. So additional time will be asked from the
participating patients. In our view patients participating in this study will
undergo no additional risks.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Patients eligible for this trial are patients with clinical and radiological
knee or hip OA who are scheduled for a primary TKA or THA, and willing to
comply with the study protocol.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: TKA or THA for a diagnosis other than OA,
uncontrolled cardiovascular disease or hypertension, history of neuromuscular
disorder that affects lower extremity function, terminal illness, plans to have
another joint replacement during study follow-up, not able to attend follow-up
measurements, not able to attend the PPT in primary setting, serious adverse
events during surgery or directly thereafter, serious psychiatric disorders, or
insufficient command of the Dutch language, spoken and/or written.
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 | NL61763.078.17 |
| OMON | NL-OMON27356 |