Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity

Schulthess Klinik

Status: Completed

Conditions: Rotator Cuff Tear; Trapeziometacarpal Osteoarthritis; Degenerative Arthritis of Left Glenohumeral Joint; Degenerative Arthritis of Right Glenohumeral Joint; Rotator Cuff Tear Arthropathy

Treatments: Procedure: Operated RCR Patients; Procedure: Resection interposition suspension arthroplasty (RISA); Procedure: Operated TSA Patients

Study type: Observational

Funder types: Other

Identifiers

NCT01954433

CUA-OrthopaedicsOE-CIP-v2.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

450 participants in 6 patient groups

Operated TSA Patients

Description:

Patients with glenohumeral arthritis and/or rotator cuff tear arthropathy who were operated and received a total shoulder prosthesis

Treatment:

Procedure: Operated TSA Patients

Non-operated TSA Patients

Description:

TSA-patients, indicated for treatment with a total shoulder prosthesis, who decided not to operate

Operated RCR Patients

Description:

Patients with rotator cuff tear who were operated and received a rotator cuff reconstruction by arthroscopy

Treatment:

Procedure: Operated RCR Patients

Non-operated RCR Patients

Description:

RCR-patients, indicated for rotator cuff reconstruction by arthroscopy, who decided not to operate

Operated TMC OA Patients

Description:

Patients with trapeziometacarpal (TMC) osteoarthritis who were operated and received a resection interposition suspension arthroplasty of the TMC joint

Treatment:

Procedure: Resection interposition suspension arthroplasty (RISA)

Non-operated TMC OA Patients

Description:

TMC OA-patients, indicated for surgical treatment (resection interposition suspension arthroplasty), who decided not to operate