Patient Satisfaction Clinical Trial
— FCDOfficial title:
The Fast-track Centre for Hip and Knee Replacement Prospective Database on Preoperative Patientcharacteristics and Postoperative Complications
NCT number | NCT05613439 |
Other study ID # | FC-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | December 31, 2027 |
This is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 Danish dedicated arthroplasty departments from all five health regions in Denmark. The registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. Follow-up is based on electronical medical records by dedicated nurses with physician backup and includes Clavien-Dindo and Comprehensive Complication Index scoring. All patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. Finally, a machine-learning algorithm for identification of "high-risk" patients based on he preoperative data is included.
Status | Recruiting |
Enrollment | 10000 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age >18 years - non-malignant surgery - danish social security number - elective procedure Exclusion Criteria: - unwilling to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Denmark | Bispebjerg University Hospital | Copenhagen | Capital Region |
Denmark | Aalborg University Hospital, Farsø | Farsø | Region Of Northern Judland |
Denmark | Gentofte University Hospital | Gentofte | Capital Region |
Denmark | Gødstrup Hospital | Herning | Region Of Middle Judland |
Denmark | Hvidovre Hospital | Hvidovre | Capital Region |
Denmark | Næstved Hospital | Næstved | Region Seeland |
Denmark | University Hospital Svendborg | Svendborg | Region Of Southern Denmark |
Denmark | Lillebaelt Hospital, Vejle | Vejle | Region Of Sourthern Denmark |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Aalborg University Hospital, Bispebjerg Hospital, Gødstrup Hospital, Hvidovre University Hospital, Naestved Hospital, Region of Southern Denmark, Svendborg Hospital, Sygehus Lillebaelt, The Novo Nordic Foundation, University Hospital, Gentofte, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | return to work in day-surgery | changes in work status and time to return to work in day-surgery procedures | 30 days postoperatively | |
Other | patient satisfaction and patient reported outcome measures1 | collection of data on patient satisfaction and function after surgery using the EQ-5D-5L (score from 0-100 with increasing score indicating better health) | Baseline, 90 and 365 days postoperatively | |
Other | patient satisfaction and patient reported outcome measures, THA only. | collection of data on patient satisfaction and function after surgery using the Oxford Hip Score (range from 0-48 with increasing score indicating better function). | Baseline, 90 and 365 days postoperatively | |
Other | patient satisfaction and patient reported outcome measures, TKA only. | collection of data on patient satisfaction and function after surgery using the Oxford Knee score (range from 0-48 with increasing score indicating better function). | Baseline, 90 and 365 days postoperatively | |
Primary | Fraction of unselected patients able to undergo day-surgery procedures | The fraction patients eligible for day-surgery who are discharged on day of surgery. | 7 days postoperatively | |
Primary | postoperative morbidity | postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery. | 90 days postoperatively | |
Primary | postoperative morbidity Clavien-Dindo | Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Clavien-Dindo index. | 90 days postoperatively | |
Primary | postoperative morbidity CCI | Postoperative morbidity resulting in prolonged (>2 days) hospitalisation, readmissions or mortality 90 days after surgery according to the Comprehensive Complication Index | 90 days postoperatively | |
Secondary | Healthcare utilisation in day-surgery | Registration of emergency room visits, visits to general practitioners and use of medical emergency services within 30 days after having hip or knee replacement as day-surgery procedure. | 30 days postoperatively |
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