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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by AO Clinical Investigation and Documentation
Sponsor:
Collaborator:
Synthes GmbH
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01288066
First received: January 31, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Procedure: Hemiarthroplasty
Procedure: Total arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • The Constant score assessment of shoulder function and pain [ Time Frame: Baseline to 5 years postsurgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Constant score [ Time Frame: 6 months, 1 year, 3 years ] [ Designated as safety issue: No ]
  • Shoulder Pain and Disability Index (SPADI) [ Time Frame: 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
  • Duration of surgery [ Time Frame: 1-2 days ] [ Designated as safety issue: No ]
  • Numbers of adverse events [ Time Frame: Baseline to 5 years follow-up ] [ Designated as safety issue: No ]
  • Survivorship of implants [ Time Frame: Baseline to 5 years follow-up ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Baseline, 6 months, 1 year, 3 years, 5 years ] [ Designated as safety issue: No ]
    Quality of life is assessed using the Euroqol - 5 Dimensions (EQ-5D) questionnaire


Estimated Enrollment: 94
Study Start Date: September 2011
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288066

Contacts
Contact: Denise Schmid 0041 44 200 24 77 denise.schmid@aofoundation.org

Locations
Austria
Medizinische Universität Recruiting
Innsbruck, Austria, 6020
Contact: Michael Blauth, Prof         
Principal Investigator: Michael Blauth, Prof         
Germany
BG Unfallklinik Frankfurt Recruiting
Frankfurt, Germany, 60389
Contact: Frederic Welsch, M.D         
Principal Investigator: Frederic Welsch, M.D         
Universitätsklinikum Freiburg Recruiting
Freiburg, Germany
Principal Investigator: Norbert Suedkamp, MD         
Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen Recruiting
Laatzen, Germany, 30880
Contact: Thomas Berndt, M.D         
Principal Investigator: Thomas Berndt, M.D         
Sweden
Universitetssjukhuset Ortopedicentrum i Östergötland Recruiting
Linköping, Sweden, 58185
Contact: Lars Adolfsson, M.D         
Principal Investigator: Lars Adolfsson, M.D         
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Synthes GmbH
Investigators
Principal Investigator: Norbert Suedkamp, MD Universitätsklinikum Freiburg, Deutschland
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01288066     History of Changes
Other Study ID Numbers: Epoca Hemi vs. Total 2011
Study First Received: January 31, 2011
Last Updated: March 25, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by AO Clinical Investigation and Documentation:
Shoulder
Total arthroplasty
Hemiarthroplasty
Resurfacing
Glenoid
Constant score

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014