Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System (Epoca H vs T)

A Randomized Multicenter Study Comparing the Effectiveness of Hemi Versus Total Shoulder Arthroplasty in Patients With a Degenerative Joint Disease

The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power. In this study, patients are randomly allocated to a treatment with a hemi- or total shoulder arthroplasty using implants of the Epoca system. The primary objective is the comparison of pain and function between the treatment groups after 5 years using the Constant score.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Hemiarthroplasty; Procedure: Total arthroplasty

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitat
• Germany
  • Freiburg, Germany
    • Universitätsklinikum Freiburg
  • Laatzen, Germany, 30880
    • Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen
• Sweden
  • Linköping, Sweden, 58185
    • Universitetssjukhuset Ortopedicentrum i Östergötland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years and older
• Primary or secondary omarthrosis (eg, rheumatoid arthritis, avascular head necrosis)
• Glenoid morphologic type A1, A2 or B1 according to Walch
• Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
• Written informed consent

Exclusion Criteria:

Preoperative:

• Posttraumatic omarthrosis
• Biconcave aspect of glenoid (Walch type B2)
• Retroversion of glenoid more than 25° (Walch type C)
• "Epoca Reko" prosthesis
• Humerus fractures
• Patients with a severe systemic disease: class III-IV according to the American Society of Anaesthesiologists physical status classification (ASA)
• Substance abuse that would preclude reliable assessment
• Pregnancy
• Prisoners
• Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Intraoperative:

• Full thickness tear of rotator cuff
• Indication for hemiarthroplasty only
• Indication for total arthroplasty only
• Intraoperative decision to use implants other than Epoca

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hemiarthroplasty; Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system.	Procedure: Hemiarthroplasty; 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.
Other: Total arthroplasty; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Constant score assessment of shoulder function and pain	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.	Baseline to 5 years postsurgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score		6 months, 1 year, 3 years
Shoulder Pain and Disability Index (SPADI)		6 months, 1 year, 3 years, 5 years
Duration of surgery		1-2 days
Numbers of adverse events		Baseline to 5 years follow-up
Survivorship of implants		Baseline to 5 years follow-up
Quality of life related to health	Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire	Baseline, 6 months, 1 year, 3 years, 5 years

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Collaborators: Synthes GmbH
• Investigators: Principal Investigator: Norbert Suedkamp, MD, Universitätsklinikum Freiburg, Deutschland

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (Estimated): February 2, 2011

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Hemiarthroplasty; Shoulder; Glenoid; Constant score; Resurfacing; Total arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Epoca Hemi vs. Total 2011