- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954433
Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity - Health Economic Investigation (Cost-effectiveness and Cost-utility Analyses) With Before and After Surgery Comparison
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8008
- Schulthess Klinik
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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
Description
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 joint
- Patients with rheumatoid arthritis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Operated TSA Patients
Patients with glenohumeral arthritis and/or rotator cuff tear arthropathy who were operated and received a total shoulder prosthesis
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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
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Non-operated TSA Patients
TSA-patients, indicated for treatment with a total shoulder prosthesis, who decided not to operate
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Operated RCR Patients
Patients with rotator cuff tear who were operated and received a rotator cuff reconstruction by arthroscopy
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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.
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Non-operated RCR Patients
RCR-patients, indicated for rotator cuff reconstruction by arthroscopy, who decided not to operate
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Operated TMC OA Patients
Patients with trapeziometacarpal (TMC) osteoarthritis who were operated and received a resection interposition suspension arthroplasty of the TMC joint
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One of five surgical techniques can be used in this study, as routinely performed by each surgeon:
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Non-operated TMC OA Patients
TMC OA-patients, indicated for surgical treatment (resection interposition suspension arthroplasty), who decided not to operate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Cost-effectiveness and cost-utility of the targeted interventions
Time Frame: Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)
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To calculate the cost-effectiveness and cost-utility of the targeted interventions we will assess the following parameters before and after surgery:
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Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)
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Change in quality of life
Time Frame: preOP, immediately preOP, 2 weeks, 3, 6, 12 months postOP respectively 6 and 12 months after enrollment for non-operated patients
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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.
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preOP, immediately preOP, 2 weeks, 3, 6, 12 months postOP respectively 6 and 12 months after enrollment for non-operated patients
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in quality of life in TSA- and RCR-Patients after 2 years
Time Frame: 2 years postOP (/ after enrollment for non-operated patients)
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Quality of life (utilities) derived using EQ-5D-5L
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2 years postOP (/ after enrollment for non-operated patients)
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Complications
Time Frame: From enrollment up to 1 or 2 years after surgery
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Patient-level risk of intervention-related complications (during non-operative management, intra-operative, post-operative including events leading to revision surgeries).
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From enrollment up to 1 or 2 years after surgery
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Local imaging Parameters (assessed from MRT, ultrasound, radiographs)
Time Frame: TSA: preOP, 6 months, 1 and 2 years postOP, RCR: preOP, 6 months postOP, TMC OA: preOP
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TSA preOP:
TSA postOP:
RCR preOP:
RCR postOP:
TMC OA preOP:
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TSA: preOP, 6 months, 1 and 2 years postOP, RCR: preOP, 6 months postOP, TMC OA: preOP
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Change of Constant (Murley) score (CS) due to surgery in TSA- and RCR-patients
Time Frame: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
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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
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Change of range of motion due to surgery in TSA- and RCR-patients
Time Frame: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
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Additional to th Constant score we assess the
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preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
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Change of Kapandji index and grip + key pinch strength due to surgery in TMC OA-patients
Time Frame: preOP, immediately preOP, 3, 6, 12 months postOP
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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
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Change of Shoulder Pain and Disability Index (SPADI) during study participation in TSA-patients
Time Frame: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
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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.
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preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
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Change in Oxford Shoulder Score (OSS) during study participation in RCR-patients
Time Frame: preOP, immediately preOP, 3, 6, 12 and 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
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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.
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preOP, immediately preOP, 3, 6, 12 and 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
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Change in Michigan Hand Outcomes Questionnaire (brief MHQ) during study participation in TMC OA-patients
Time Frame: preOP, immediately preOP, 3, 6, 12 months postOP; respectively 6 and 12 months after enrollment for non-operated patients
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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
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Change in Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) during study participation in TSA- and TMC OA-patients
Time Frame: 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.
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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.
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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.
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Change in Subjective shoulder value (SVV) during study participation in TSA- and RCR-patients
Time Frame: RCR + TSA: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
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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.
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RCR + TSA: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
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Change in general health during study participation
Time Frame: 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
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The outcome measure "general health" is a composite of these three questions:
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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
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Change in level of satisfaction during study participation
Time Frame: 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
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The outcome measure "level of satisfaction" is a composite of these two questions:
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthias P Flury, Dr. med., Schulthess Klinik
- Study Director: Laurent Audigé, DVM PhD, Schulthess Klinik
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUA-OrthopaedicsOE-CIP-v2.0
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