Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity (NCT01954433) | Clinical Trial Compass
CompletedNot Applicable
Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
Switzerland450 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Specific inclusion Criteria:
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
or
TMC OA:
* patients diagnosed with TMC OA
* indicated for surgical treatment by resection interposition suspension arthroplasty of the TMC joint
Exclusion Criteria:
* 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
Specific exclusion Criteria:
* Other joints operated in the same session, except arthrodesis of the metacarpophalangeal (MCP) I jo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cost-effectiveness and cost-utility of the targeted interventions
Timeframe: Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)
2
Change in quality of life
Timeframe: preOP, immediately preOP, 2 weeks, 3, 6, 12 months postOP respectively 6 and 12 months after enrollment for non-operated patients