- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00754416
S.E.S Shoulder Arthroplasty Data Collection
March 6, 2017 updated by: Zimmer Biomet
A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis
This observational study intends to collect efficacy and safety data on S.E.S shoulder system
Study Overview
Status
Terminated
Conditions
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.
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Schilde, Belgium
- De Dreef Van Zonnebos 13
-
-
-
-
-
Annecy, France
- Clinique Générale
-
Chambery, France
- Clinique St Joseph
-
Dax, France
- Centre Hospitalier General
-
Maxeville, France
- Clinique Chirurgicale Orthopédique A.D.R.
-
Montpellier, France
- Clinique St Jean
-
Paris, France
- IRCOS
-
Pessac, France
- Clinique St Martin
-
Saint Herblain, France
- Polyclinique de l'Atlantique
-
St Etienne, France
- Clinique Mutualiste
-
St Laurent du Var, France
- Institut A. Tzanck
-
St Laurent du Var, France
- Institut Calot
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Consecutive series of patients received S.E.S prostheses
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
S.E.S prosthesis
Consecutive series of patients with a S.E.S prosthesis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Constance and oxford Scores
Time Frame: 6m, 1yr, 2yr, 3yr, 4yr and 5 yr
|
6m, 1yr, 2yr, 3yr, 4yr and 5 yr
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complication
Time Frame: Any time
|
Any time
|
Patient Satisfaction
Time Frame: 6m,1yr,2yr,3yr,4yr and 5yr
|
6m,1yr,2yr,3yr,4yr and 5yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurent BEGUIN, MD, Centre hospitalier Bellevue
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
September 16, 2008
First Submitted That Met QC Criteria
September 17, 2008
First Posted (Estimate)
September 18, 2008
Study Record Updates
Last Update Posted (Actual)
March 7, 2017
Last Update Submitted That Met QC Criteria
March 6, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMET FR 02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis
-
Northumbria Healthcare NHS Foundation TrustUniversity of YorkRecruitingKnee Arthritis | Hip ArthritisUnited Kingdom
-
MedShape, IncOrthopedic Foot and Ankle Center, Ohio; CurveBeam LLCRecruitingAnkle Arthritis | Arthritis FootUnited States
-
MedShape, IncUniversity of Alabama at BirminghamRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
University of Alabama at BirminghamMedShape, IncRecruiting
-
MedShape, IncThe University of Texas Medical Branch, GalvestonRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
Chang Gung Memorial HospitalNot yet recruitingArthritis Knee | Arthritis HipTaiwan
-
MedShape, IncSaint Alphonsus Medical GroupUnknownAnkle Arthritis | Foot ArthritisUnited States
-
Saint Alphonsus Regional Medical CenterCompletedArthritis Knee | Arthritis of HipUnited States
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoCompleted
-
Smith & Nephew, Inc.TerminatedRheumatoid Arthritis | Traumatic Arthritis | Osteo Arthritis ShouldersUnited States