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| Name | Class |
|---|---|
| Winterthur Institute of Health Economics (WIG), Switzerland | UNKNOWN |
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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.
Among various recognized methods used to assess the benefits and value of medical services, cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) are taking an increasingly important role. Over recent years, economic evaluations gained interest in orthopedics, suggesting the inclusion of economic factors in addition to traditional outcome measures in the evaluation of surgical interventions.
This is a prospective mono-center observational study involving three independent patient groups (Total shoulder prosthesis for arthritis (TSA), Arthroscopic repair of rotator cuff tears (RCR), Trapeziectomy for Trapeziometacarpal Osteoarthritis (TMC OA)) of 150 patients each. Before-and-after comparisons will be made: Cost-effectiveness and cost-utility data collected post-operatively up to one (TMC OA) and two years (TSA and RCR) will be compared with those collected up to one year pre-operatively. Eligible patients unwilling to receive surgery will be followed-up for one and two years, respectively, to allow for a parallel comparison group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operated TSA Patients | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life in TSA- and RCR-Patients after 2 years | Quality of life (utilities) derived using EQ-5D-5L | 2 years postOP (/ after enrollment for non-operated patients) |
| Complications |
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Inclusion Criteria:
Specific inclusion Criteria:
TSA:
RCR:
or
TMC OA:
Exclusion Criteria:
Specific exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias P Flury, Dr. med. | Schulthess Klinik | Principal Investigator |
| Laurent Audigé, DVM PhD | Schulthess Klinik | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33973108 | Derived | 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. |
| Label | URL |
|---|---|
| Schulthess Klinik | View source |
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| Operated RCR Patients | Procedure | 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. |
|
| Resection interposition suspension arthroplasty (RISA) | Procedure | One of five surgical techniques can be used in this study, as routinely performed by each surgeon:
|
|
Patient-level risk of intervention-related complications (during non-operative management, intra-operative, post-operative including events leading to revision surgeries).
| From enrollment up to 1 or 2 years after surgery |
| Local imaging Parameters (assessed from MRT, ultrasound, radiographs) | TSA preOP:
TSA postOP:
RCR preOP:
RCR postOP:
TMC OA preOP:
| 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 | The Constant (Murley) score is possibly the most commonly used tool for assessment of shoulder function. The physician asks and documents answers to Quality of life questions (pain and activity of daily living, ability to work, sleep, sports and leisure) and certain clinical parameters (active range of motion, abduction strength). The different scales will be summed and normalized to 0 = worst to 100 = best. A German version is available for clinical use. With the CS we can assess the change and gain in functional shoulder outcome. | 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 | Additional to th Constant score we assess the
| preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP |
| Change of Kapandji index and grip + key pinch strength due to surgery in TMC OA-patients | The ability to oppose the thumb of both hands will be quantified using the Kapandji index. The flexion/extension of the metacarpo-phalangeal (MCP) and inter-phalangeal (IP) joint of the affected and contralateral thumb will be measured with an electrical Goniometer (ELINK, Biometrics Ltd., Gwent, UK). Grip strength as well as key pinch strength of both hands will be measured with the help of an electrical dynamometer and pinch gauge (ELINK, Biometrics Ltd., Gwent, UK). Three records will be taken and the mean value will be taken for analyses. The standardized testing position as recommended by the American Society of Hand Therapists will be used. | preOP, immediately preOP, 3, 6, 12 months postOP |
| Change of Shoulder Pain and Disability Index (SPADI) during study participation in TSA-patients | The Shoulder Pain and Disability Index (SPADI) is a short, self-administered questionnaire that provides an item scoring by a visual analogue scale (VAS) from 0 (no pain/no difficulty, i.e. best) to 11 (worst pain imaginable/so difficult required help, i.e. worst). Five items assess pain and 8 items disability of the arm (function). The unweighted means of the 5 pain and the 8 function items will be transformed into the scale from 0 (=worst) to 100 (=best) for both scales and are used to determine pain and function scores. The average of these two scores then gives the total SPADI score. A validated German version is available. | preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients |
| Change in Oxford Shoulder Score (OSS) during study participation in RCR-patients | The OSS is a condition-specific questionnaire developed for patients with a degenerative or inflammatory state of the shoulder. It contains 12 items to be answered by the patient independently, which deal with pain (degree, time point) and possible handicaps in private and professional life. There are five categories of response for every question, corresponding to a score ranging from 0 to 4. Scores are combined to give a single score, with a range from 0 (worst outcome) to 48 (best outcome). The score can also be standardized from 0 to 100 (best) for comparison with other outcome instruments. A German version of this questionnaire is available and it is suitable for patient-based outcome after rotator cuff repair. | preOP, immediately preOP, 3, 6, 12 and 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients |
| Change in Michigan Hand Outcomes Questionnaire (brief MHQ) during study participation in TMC OA-patients | The Michigan Hand Outcomes Questionnaire MHQ was specifically designed to measure health state domains important to patients with hand disorders. In contrast to the widely applied DASH, the MHQ seems to be more sensitive to functional changes in hand patients. Compared to the DASH and Patient Evaluation Measure, the MHQ shows the highest correlation in finger patients with grip strength and range of motion. In this study we will use a short version of the MHQ that includes only 12 questions for patients with acute or chronic disorders of the hand. The answers are rated on a 5-point Likert scale and scores are normalized on a scale of 0 to 100. The brief MHQ demonstrated an excellent test-retest reliability. | preOP, immediately preOP, 3, 6, 12 months postOP; respectively 6 and 12 months after enrollment for non-operated patients |
| Change in Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) during study participation in TSA- and TMC OA-patients | The Disability of the Arm, Shoulder and Hand questionnaire (DASH) is a comprehensive self-administered questionnaire about symptoms and functioning of the entire upper extremity. The DASH enquires about the ability to perform simple and complex activities of daily living (ADL) that are commonly performed with either one or both arms. The total score is derived from the unweighted mean of 30 items, of which at least 27 have to be answered. The QuickDASH is a more efficient version of the DASH outcome measure that appears to retain its measurement properties. It contains eleven items and is similar with regard to scores and properties to the full DASH. A validated full-length German version is available that can be used in the shortened version. | TMC OA + TSA: preOP, immediately preOP, 3, 6, 12 months postOP. TSA additionally: 24 months. 6, 12 and 24 months after enrollment for non-operated patients. |
| Change in Subjective shoulder value (SVV) during study participation in TSA- and RCR-patients | The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" It is an easily administered measure of shoulder function. | RCR + TSA: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients |
| Change in general health during study participation | The outcome measure "general health" is a composite of these three questions:
| preOP, immediately preOP, 3, 6, 12 months postOP. TSA + RCR additionally: 24 months postOP; ; respectively 6, 12 and 24 months after enrollment for non-operated patients |
| Change in level of satisfaction during study participation | The outcome measure "level of satisfaction" is a composite of these two questions:
| preOP, immediately preOP, 3, 6, 12 months postOP. TSA + RCR additionally: 24 months postOP. ; 6, 12 and 24 months after enrollment for non-operated patients |
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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