No registrations found.
ID
Source
Brief title
Health condition
Postoperative physiotherapy after total knee or hip arthroplasty for osteoarthritis (OA)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference between both groups in change between baseline and 3 month postoperative KOOS-PS / HOOS-PS score will be used as primary outcome.
Besides, differences in medical consumption, adverse events, absence from work or decreased productivity, and patient costs, will be assessed
Secondary outcome
Difference in scores of OKS/OHS, NRS, EQ5D, performance tests, physical activity level, as well as anchor questions, and satisfaction question.
Background summary
To evaluate the cost-effectiveness of the optimized, treat-to-target PPT strategy in TKA and THA patients compared to usual PPT. The hypothesis is that with the optimized strategy superior functional outcome can be achieved to usual care, with lower costs (superiority study)
Study objective
Primary objective
1. To assess whether the functional outcome of an optimized, personalized treat-to-target PPT strategy after total knee arthroplasty (TKA) and total hip arthroplasty (THA) is superior to usual care PPT after 3 months follow-up.
2. To assess whether an optimized, personalized PPT strategy is cost-effective compared to usual care PPT.
Study design
baseline (preoperative)
6 weeks, 3,6,9 and 12 months after surgery
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. The final protocol has been registered.
Usual care: Current PPT delivery.
Lichelle Groot
Rotterdam
The Netherlands
010-7034070/0633331007
patio@zorgevaluatienederland.nl
Lichelle Groot
Rotterdam
The Netherlands
010-7034070/0633331007
patio@zorgevaluatienederland.nl
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 psychiatric disorders, or insufficient command of the Dutch language, spoken and/or written.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6933 |
| NTR-old | NTR7129 |
| CCMO | NL61763.078.17 |
| OMON | NL-OMON55756 |