Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System (Epoca H vs T)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized Multicenter Study Comparing the Effectiveness of Hemi- Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease|
- The Constant score assessment of shoulder function and pain [ Time Frame: Baseline to 5 years postsurgery ]The primary outcome measure is the difference between the Constant score assessment of shoulder function and pain at baseline and 5 years after surgery. This difference is assessed for each individual patient.
- Constant score [ Time Frame: 6 months, 1 year, 3 years ]
- Shoulder Pain and Disability Index (SPADI) [ Time Frame: 6 months, 1 year, 3 years, 5 years ]
- Duration of surgery [ Time Frame: 1-2 days ]
- Numbers of adverse events [ Time Frame: Baseline to 5 years follow-up ]
- Survivorship of implants [ Time Frame: Baseline to 5 years follow-up ]
- Quality of life [ Time Frame: Baseline, 6 months, 1 year, 3 years, 5 years ]Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||February 2022|
|Estimated Primary Completion Date:||December 2021 (Final data collection date for primary outcome measure)|
Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system.
Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.
Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system.
Procedure: Total arthroplasty
Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.
Shoulder arthroplasty is accepted as the treatment of choice for improved function with minimum pain in well-selected patients. A persistent discussion remains as to whether replacement of the glenoid (ie, total arthroplasty) should be performed. Possible advantages of glenoid replacement include decreased pain compared to hemiarthroplasty with a metal-on-bone articulation, increased stability due to the conforming glenoid component, and lateralization of the joint center providing improved range of motion and abduction strength. Potential complications of glenoid replacement are implant loosening and loss of glenoid bone stock.
If a hemiarthroplasty is performed, glenoid replacement and related complications are avoided. In addition, hemiarthroplasty requires less surgical time and is less expensive than total shoulder arthroplasty.
To date, there is no evidence to answer the clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease. In this study, both the stemmed Epoca humeral component (Epoca Stem) and the Epoca Resurfacing Head (Epoca RH) are included. While the stemmed prosthesis was developed both for nonreconstructable fractures and omarthroses, the humeral resurfacing head implant was designed specifically for use in degenerative diseases of the shoulder joint.
This randomized multicenter study aims to compare the efficacy of hemi versus total shoulder arthroplasty using Epoca RH or Epoca Stem in patients with degenerative joint diseases. The primary aim of the present study is to demonstrate that the Constant score assessing shoulder function and pain is higher in the patient group treated with total arthroplasty compared to the hemiarthroplasty group after 5 years. The secondary aims of the study are to assess differences in the Shoulder Pain and Disability Index (SPADI), duration of surgery, rates of local and general adverse events and relationship to the device or treatment under investigation, survivorship of the implants, and quality of life after 6 months, 1, 3 and 5 years between the treatment groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288066
|Innsbruck, Austria, 6020|
|Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen|
|Laatzen, Germany, 30880|
|Universitetssjukhuset Ortopedicentrum i Östergötland|
|Linköping, Sweden, 58185|
|Principal Investigator:||Norbert Suedkamp, MD||Universitätsklinikum Freiburg, Deutschland|