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van CCT (UK)

van CCT (UK)

Physiotherapeutic Treat-to-target Intervention after Orthopaedic surgery; a cost-effectiveness study

- candidate number28770
- NTR NumberNTR7129
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-apr-2018
- Secondary IDsNL61763.078.17 
- Public TitlePhysiotherapeutic Treat-to-target Intervention after Orthopaedic surgery; a cost-effectiveness study
- Scientific TitlePhysiotherapeutic Treat-to-target Intervention after Orthopaedic surgery; a cost-effectiveness study
- hypothesisPrimary 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.
- Healt Condition(s) or Problem(s) studiedPost operative, Physiotherapy, Total knee arthroplasty, Total Hip Arthroplasty, Osteoarthritis
- Inclusion criteriaPatients 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 criteriaA 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2018
- planned closingdate1-mei-2020
- Target number of participants640
- InterventionsTreat-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.
- Primary outcomeThe 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 outcomeDifference in scores of OKS/OHS, NRS, EQ5D, performance tests, physical activity level, as well as anchor questions, and satisfaction question.
- Timepointsbaseline (preoperative)
6 weeks, 3,6,9 and 12 months after surgery
- Trial web
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Leading the Change
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD5-apr-2018 - 15-apr-2018

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