NCT00754416

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
2 countries

12 active sites

Status
terminated

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

Study Start

First participant enrolled

March 1, 2003

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

13.5 years

First QC Date

September 16, 2008

Last Update Submit

March 6, 2017

Conditions

Arthritis

Keywords

Shoulder Replacement

Outcome Measures

Primary Outcomes (1)

  • Constance and oxford Scores

    6m, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary Outcomes (2)

  • Complication

    Any time

  • Patient Satisfaction

    6m,1yr,2yr,3yr,4yr and 5yr

Study Arms (1)

S.E.S prosthesis

Consecutive series of patients with a S.E.S prosthesis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive series of patients received S.E.S prostheses

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

De Dreef Van Zonnebos 13

Schilde, Belgium

Location

Clinique Générale

Annecy, France

Location

Clinique St Joseph

Chambéry, France

Location

Centre Hospitalier Général

Dax, France

Location

Clinique Chirurgicale Orthopédique A.D.R.

Maxéville, France

Location

Clinique St Jean

Montpellier, France

Location

IRCOS

Paris, France

Location

Clinique St Martin

Pessac, France

Location

Clinique Mutualiste

Saint-Etienne, France

Location

Polyclinique de l'Atlantique

Saint-Herblain, France

Location

Institut A. Tzanck

Saint-Laurent-du-Var, France

Location

Institut Calot

Saint-Laurent-du-Var, France

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Laurent BEGUIN, MD

    Centre hospitalier Bellevue

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2008

First Posted

September 18, 2008

Study Start

March 1, 2003

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

FR(11)BE(1)