Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
1 other identifier
observational
450
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2020
CompletedOctober 22, 2020
October 1, 2020
5.6 years
September 17, 2013
October 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (13)
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
- +8 more secondary outcomes
Study Arms (6)
Operated TSA Patients
Patients with glenohumeral arthritis and/or rotator cuff tear arthropathy who were operated and received a total shoulder prosthesis
Non-operated TSA Patients
TSA-patients, indicated for treatment with a total shoulder prosthesis, who decided not to operate
Operated RCR Patients
Patients with rotator cuff tear who were operated and received a rotator cuff reconstruction by arthroscopy
Non-operated RCR Patients
RCR-patients, indicated for rotator cuff reconstruction by arthroscopy, who decided not to operate
Operated TMC OA Patients
Patients with trapeziometacarpal (TMC) osteoarthritis who were operated and received a resection interposition suspension arthroplasty of the TMC joint
Non-operated TMC OA Patients
TMC OA-patients, indicated for surgical treatment (resection interposition suspension arthroplasty), who decided not to operate
Interventions
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.
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
Eligibility Criteria
* 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
You may qualify if:
- Male and female patient aged 18 years and over
- Patient willing and able to give written informed consent to participate in the study including all pre-surgical and post-surgical follow-up examinations
- Patient authorizing that their health insurance be contacted to provide health-related costs for the purpose of this study
- TSA:
- patients diagnosed with primary or secondary glenohumeral arthritis and/or rotator cuff tear arthropathy
- indicated for treatment with a total anatomic or reverse shoulder prosthesis or
- RCR:
- patients diagnosed with partial or complete rotator cuff tear
- indicated for rotator cuff reconstruction by arthroscopy
- TMC OA:
- patients diagnosed with TMC OA
- indicated for surgical treatment by resection interposition suspension arthroplasty of the TMC joint
You may not qualify if:
- General medical contraindication to surgery
- Revision operations
- Known hypersensitivity to the materials used
- Tumour / malignoma
- Addiction or other disorders (e.g. neuromuscular, psychiatric or metabolic disorder) that would preclude accurate evaluation
- Recent history of substance abuse
- Legal incompetence
- Pregnant women
- Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
- Other joints operated in the same session, except arthrodesis of the metacarpophalangeal (MCP) I joint
- Patients with rheumatoid arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schulthess Klinik
Zurich, 8008, Switzerland
Related Publications (1)
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.
PMID: 33973108DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias P Flury, Dr. med.
Schulthess Klinik
- STUDY DIRECTOR
Laurent Audigé, DVM PhD
Schulthess Klinik
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
October 1, 2013
Study Start
November 1, 2013
Primary Completion
June 7, 2019
Study Completion
October 12, 2020
Last Updated
October 22, 2020
Record last verified: 2020-10