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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Orthopaedic implant for total shoulder replacement
Universitair Ziekenhuis
Ghent, Belgium
Clinique Generale D'Annecy
Annecy, France
CHRU Reims Hôpital Maison Blanche
Reims, France
Polyclinique de l'Atlantique
Saint-Herblain, France
Krankenhaus Munchen Bogenhausen
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.
Time frame: 2 years
Postoperative functionality at 12weeks, 1, 2, 5 and 10 years through a difference in the Constant score, ASES score, U-Penn score and EQ-5D as compared with pre-treatment scores.
Time frame: 12weeks, 1, 2, 5 and 10 years
Determine implant survivorship and surgical revision information at 1, 2, 5 and 10 years via Kaplan-Meier survival analysis.
Time frame: 1, 2, 5 and 10 years
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München, Germany