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Clinical Trials/NCT00754416
NCT00754416
Terminated
Not Applicable

A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis

Zimmer Biomet12 sites in 2 countries100 target enrollmentMarch 2003
ConditionsArthritis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis
Sponsor
Zimmer Biomet
Enrollment
100
Locations
12
Primary Endpoint
Constance and oxford Scores
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

This observational study intends to collect efficacy and safety data on S.E.S shoulder system

Detailed Description

The S.E.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
September 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A pre-operative level of pain and function the same as for conventional joint replacement
  • A likelihood of obtaining relief of pain and improved function
  • Full skeletal maturity
  • Ability to follow instructions
  • Good general health for age
  • Willing to return for follow-up evaluations

Exclusion Criteria

  • Glenohumeral joint infection, osteomyelitis
  • Neuro-muscular complications
  • Inability to co-operate with and complete the study

Outcomes

Primary Outcomes

Constance and oxford Scores

Time Frame: 6m, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary Outcomes

  • Complication(Any time)
  • Patient Satisfaction(6m,1yr,2yr,3yr,4yr and 5yr)

Study Sites (12)

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