Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Post Traumatic Injury to Shoulder, Revision Surgery of a Failed Anatomic Shoulder Prosthesis, Rheumatoid Arthritis
Conditions
Keywords
total shoulder replacement, rotator cuff, osteoarthritis, rheumatoid arthritis, Delta Extend
Brief summary
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.
Interventions
DEVICEDelta Xtend Reverse Total Shoulder
Orthopaedic implant for total shoulder replacement
Sponsors
DePuy International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects, aged less than 85 years inclusive. * Subjects who have cuff tear arthropathy, osteoarthritis with cuff deficiency, rheumatoid arthritis, post traumatic injury, or a need for revision surgery of a failed anatomic prosthesis in the left or right shoulder, which requires (total) shoulder arthroplasty. * Subjects with radiographic evidence of sufficient bone stock to seat and support the Delta XtendÔ Reverse Total Shoulder System. * Subjects who in the opinion of the Clinical Investigator are considered suitable for treatment with the Delta Xtend Reverse Total Shoulder System. * Patients with a life expectancy of greater than 12 months. * Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Exclusion criteria
* Male and female subjects aged 86 years or older. * Subjects with complete deltoid muscle palsy in the target joint as determined by clinical evaluation. * Subjects with active local or systemic infection or with a history of general or local infections in the target joint over the past 12 months. * Subjects with severe deformities, or tumours, that would impair fixation or proper positioning of the implant. * Subjects with no significant muscle, nerve or vascular disease. * Subjects with a pathology that, in the opinion of the Clinical Investigator, will adversely affect healing. * Known allergic reactions to implant materials (e.g. bone cement, metal, polyethylene) implant corrosion or implant wear debris. * Subjects with a known history of poor compliance to medical treatment. * Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation. * Women who are pregnant. * Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * Subjects who have participated in a clinical investigation with an investigational product in the last month. * Subjects who are currently involved in any injury litigation claims.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | 1, 2, 5 and 10 years |
Countries
Belgium, France, Germany
Outcome results
None listed