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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00737087 |
This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies. This allows for continued monitoring of the performance and safety of the prosthesis in a broader range of clinical situations.
Condition | Intervention | Phase |
---|---|---|
Cuff Tear Arthropathy Osteoarthritis With Cuff Deficiency Rheumatoid Arthritis Post Traumatic Injury to Shoulder Revision Surgery of a Failed Anatomic Shoulder Prosthesis |
Device: Delta Xtend Reverse Total Shoulder |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centred, Non-Comparative, Non-Randomised, Open, Post Marketing Investigation to Look at the Long-Term Clinical Efficacy of the Delta Xtend Reverse Total Shoulder Used in the Treatment of Shoulders With Rotator Cuff Deficiencies. |
Estimated Enrollment: | 250 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2019 |
Estimated Primary Completion Date: | March 2019 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mick Borroff, BSc, MSc | +44 113 387 7910 | mborroff@its.jnj.com |
Belgium | |
Universitair Ziekenhuis | Recruiting |
GENT, Belgium, B-9000 | |
Principal Investigator: Dr L De Wilde | |
France | |
CHRU Reims Hôpital Maison Blanche | Recruiting |
Reims, France, 51092 | |
Principal Investigator: Dr C Nérot | |
Polyclinique de l'Atlantique | Recruiting |
St Herblain, France, 44819 | |
Principal Investigator: Dr D Capon | |
Clinique Generale D'Annecy | Recruiting |
Annecy, France, 74000 | |
Principal Investigator: Dr L Lafosse | |
Germany | |
Krankenhaus Munchen Bogenhausen | Recruiting |
Munchen, Germany, 81925 | |
Principal Investigator: Dr med L Seebauer | |
Sweden | |
St Görans Hospital | Recruiting |
Stockholm, Sweden, 112 81 | |
Principal Investigator: Dr Anders Ekelund |
Principal Investigator: | Anders Ekelund | St Görans Hospital, Stockholm, Sweden |
Responsible Party: | DePuy International Ltd ( Dr Victoria Cavendish ) |
Study ID Numbers: | CT0515 |
Study First Received: | August 15, 2008 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00737087 |
Health Authority: | Belgium: Institutional Review Board; Sweden: Institutional Review Board; France: Institutional Ethical Committee; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices |
total shoulder replacement rotator cuff osteoarthritis rheumatoid arthritis Delta Extend |
Lacerations Autoimmune Diseases Musculoskeletal Diseases Osteoarthritis Arthritis |
Joint Diseases Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |