S.E.S Shoulder Arthroplasty Data Collection

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00754416

Enrollment

100

Registered

2008-09-18

Start date

2003-03-31

Completion date

2016-09-30

Last updated

2017-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Keywords

Shoulder Replacement

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Constance and oxford Scores	6m, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary

Measure	Time frame
Complication	Any time
Patient Satisfaction	6m,1yr,2yr,3yr,4yr and 5yr

Countries

Belgium, France

Outcome results