NCT01288066

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 1, 2024

Status Verified

October 1, 2023

Enrollment Period

12.8 years

First QC Date

January 31, 2011

Last Update Submit

June 28, 2024

Conditions

Osteoarthritis

Keywords

ShoulderTotal arthroplastyHemiarthroplastyResurfacingGlenoidConstant score

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Hemiarthroplasty

OTHER

Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system.

Procedure: Hemiarthroplasty

Total arthroplasty

OTHER

Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system.

Procedure: Total arthroplasty

Interventions

HemiarthroplastyPROCEDURE

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.

Hemiarthroplasty
Total arthroplastyPROCEDURE

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.

Total arthroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medizinische Universität

Innsbruck, 6020, Austria

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Klinikum Region Hannover GmbH, Klinikum Agnes-Karll Laatzen

Laatzen, 30880, Germany

Location

Universitetssjukhuset Ortopedicentrum i Östergötland

Linköping, 58185, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Norbert Suedkamp, MD

    Universitätsklinikum Freiburg, Deutschland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 2, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

July 1, 2024

Record last verified: 2023-10

Locations

SE(1)AU(1)DE(2)