NCT01954433|CompletedDMC
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Sponsor study identifier
observational
450
1 country
1
Study Start
November 2013
Actual (reported)Primary Completion
June 7, 2019
Actual (reported)Study Completion
October 12, 2020
Actual (reported)This study compares costs and effectiveness / utility of three common orthopedic surgeries in shoulder and hand from the perspective of the Swiss health system and the clinic. The cost of health care is continuously rising, making economic considerations part of the decision process, in particular for the allocation of available resources. However, cost-effectiveness and cost-utility studies of interventions in the upper extremities are rare. The purpose of this study is to gain more information and to provide a basis for the decision process.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 12, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2013
Actual (reported)October 1, 2013
Actual (reported)November 2013
Actual (reported)June 7, 2019
Actual (reported)October 12, 2020
Actual (reported)Cost-effectiveness and cost-utility of the targeted interventions
To calculate the cost-effectiveness and cost-utility of the targeted interventions we will assess the following parameters before and after surgery: * Health-related costs which include all direct and indirect costs before and after surgery (productivity via work status/salary and Work Productivity and Activity Impairment Questionnaire WPAI) * Quality-Adjusted Life years (QALYs) * Incremental Cost Effectiveness Ratio (ICER)
Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)
Change in quality of life
Quality of life (utilities) derived using EuroQoL EQ-5D-5L. The primary analysis will investigate the change between immediately before and one year after surgery.
preOP, immediately preOP, 2 weeks, 3, 6, 12 months postOP respectively 6 and 12 months after enrollment for non-operated patients
Patients with glenohumeral arthritis and/or rotator cuff tear arthropathy who were operated and received a total shoulder prosthesis
TSA-patients, indicated for treatment with a total shoulder prosthesis, who decided not to operate
Patients with rotator cuff tear who were operated and received a rotator cuff reconstruction by arthroscopy
RCR-patients, indicated for rotator cuff reconstruction by arthroscopy, who decided not to operate
Patients with trapeziometacarpal (TMC) osteoarthritis who were operated and received a resection interposition suspension arthroplasty of the TMC joint
Total shoulder prosthesis: Anatomic or reverse total shoulder replacement is a well-standardized procedure usually performed under general anesthesia with the patient in a beach-chair position
Arthroscopic rotator cuff tear reconstruction. The shoulder arthroscopy is performed according to internal and international standard procedure with patients positioned in beach-chair position under general anesthesia.
* Patients with shoulder arthritis and/or rotator cuff tear arthropathy indicated for total shoulder prosthesis (TSA) * Patients with rotator cuff tear indicated for arthroscopic rotator cuff reconstruction (RCR) * Trapeziometacarpal osteoarthritis (TMC OA) patients indicated for resection interposition suspension arthroplasty
Schulthess Klinik
Zurich, 8008, Switzerland
Marks M, Grobet C, Audige L. Validity, responsiveness and minimal important change of the EQ-5D-5L in patients after rotator cuff repair, shoulder arthroplasty or thumb carpometacarpal arthroplasty. Qual Life Res. 2021 Oct;30(10):2973-2982. doi: 10.1007/s11136-021-02849-7. Epub 2021 May 10.
Matthias P Flury, Dr. med.
Schulthess Klinik
Laurent Audigé, DVM PhD
Schulthess Klinik
450 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2013
First Posted
October 1, 2013
Study Start
November 2013
Actual (reported)Biomarkers for the Surgical Treatment of Rotator Cuff Tears
Change in quality of life in TSA- and RCR-Patients after 2 years
2 years postOP (/ after enrollment for non-operated patients)
Complications
From enrollment up to 1 or 2 years after surgery
Local imaging Parameters (assessed from MRT, ultrasound, radiographs)
TSA: preOP, 6 months, 1 and 2 years postOP, RCR: preOP, 6 months postOP, TMC OA: preOP
Change of Constant (Murley) score (CS) due to surgery in TSA- and RCR-patients
preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
Change of range of motion due to surgery in TSA- and RCR-patients
preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
TMC OA-patients, indicated for surgical treatment (resection interposition suspension arthroplasty), who decided not to operate
One of five surgical techniques can be used in this study, as routinely performed by each surgeon: 1. RISA with FCR-Ligament (flexor carpi radialis ligament) modified according to Epping 2. RISA with FCR-Ligament modified according to Weilby 3. RISA with APL-Ligament (abductor pollicis longus ligament) 4. RISA with Graftjacket modified according to Weilby 5. Resection arthroplasty
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Primary Completion
June 7, 2019
Actual (reported)Study Completion
October 12, 2020
Actual (reported)Last Updated
October 22, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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