S.E.S Shoulder Arthroplasty Data Collection | NCT00754416

Studies
S.E.S Shoulder Arthroplasty Data Collection

NCT00754416

Sponsor

Zimmer Biomet

Status

Terminated

Last Update Posted

Mar 7, 2017Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Arthritis

Interventions

Not provided

Countries

Belgium
France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Product no more sold

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 16, 2008

First Submission Date that Met QC Criteria

Sep 17, 2008

First Posted Date

Sep 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 7, 2017Actual

Name	Class
Biomet France SARL	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
S.E.S prosthesis		Consecutive series of patients with a S.E.S prosthesis.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Consecutive series of patients received S.E.S prostheses

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent BEGUIN, MD	Centre hospitalier Bellevue	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
De Dreef Van Zonnebos 13		Schilde			Belgium
Clinique Générale

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided