Clinical trial NCT01954433: Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Arthritis of Left Glenohumeral Joint
Degenerative Arthritis of Right Glenohumeral Joint
Rotator Cuff Tear Arthropathy
Rotator Cuff Tear
Trapeziometacarpal Osteoarthritis
Keywords: Cost-effectiveness analyses
Cost-utility analyses
Upper extremity
Orthopedic
Shoulder arthroplasty
Rotator cuff tear repair
Resection interposition suspension arthroplasty
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Winterthur Institute of Health Economics (WIG), Switzerland
First posted: 2013-10-01
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: 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
Secondary outcomes:
measure: Change in quality of life in TSA- and RCR-Patients after 2 years
timeFrame: 2 years postOP (/ after enrollment for non-operated patients)
measure: Complications
timeFrame: From enrollment up to 1 or 2 years after surgery
measure: Local imaging Parameters (assessed from MRT, ultrasound, radiographs)
timeFrame: TSA: preOP, 6 months, 1 and 2 years postOP, RCR: preOP, 6 months postOP, TMC OA: preOP
measure: Change of Constant (Murley) score (CS) due to surgery in TSA- and RCR-patients
timeFrame: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
measure: Change of range of motion due to surgery in TSA- and RCR-patients
timeFrame: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
measure: Change of Kapandji index and grip + key pinch strength due to surgery in TMC OA-patients
timeFrame: preOP, immediately preOP, 3, 6, 12 months postOP
measure: Change of Shoulder Pain and Disability Index (SPADI) during study participation in TSA-patients
timeFrame: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
measure: Change in Oxford Shoulder Score (OSS) during study participation in RCR-patients
timeFrame: preOP, immediately preOP, 3, 6, 12 and 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
measure: Change in Michigan Hand Outcomes Questionnaire (brief MHQ) during study participation in TMC OA-patients
timeFrame: preOP, immediately preOP, 3, 6, 12 months postOP; respectively 6 and 12 months after enrollment for non-operated patients
measure: Change in Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) during study participation in TSA- and TMC OA-patients
timeFrame: 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.
measure: Change in Subjective shoulder value (SVV) during study participation in TSA- and RCR-patients
timeFrame: RCR + TSA: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
measure: Change in general health during study participation
timeFrame: 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
measure: Change in level of satisfaction during study participation
timeFrame: 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
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik
name: Matthias P Flury, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Schulthess Klinik
name: Laurent Audigé, DVM PhD
role: STUDY_DIRECTOR
References:
citation: 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.