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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: Schulthess Klinik · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Arthritis of Left Glenohumeral Joint
• Degenerative Arthritis of Right Glenohumeral Joint
• Rotator Cuff Tear Arthropathy
• Rotator Cuff Tear
• Trapeziometacarpal Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Operated TSA Patients	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
PROCEDURE	Operated RCR Patients	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.
PROCEDURE	Resection interposition suspension arthroplasty (RISA)	One of five surgical techniques can be used in this study, as routinely performed by each surgeon: 1. RISA with FCR-Ligament (flexor carpi radialis ligament) modified according to Epping 2. RISA with FCR-Ligament modified according to Weilby 3. RISA with APL-Ligament (abductor pollicis longus ligament) 4. RISA with Graftjacket modified according to Weilby 5. Resection arthroplasty

Timeline

• Start date: 2013-11-01
• Primary completion: 2019-06-07
• Completion: 2020-10-12
• First posted: 2013-10-01
• Last updated: 2020-10-22

Locations

1 site across 1 country: Switzerland