Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Rheumatoid Arthritis, Post Traumatic Injury to Shoulder, Revision Surgery of a Failed Anatomic Shoulder Prosthesis

Intervention / Treatment
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* Device: Delta Xtend Reverse Total Shoulder


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Delta Xtend Reverse Total Shoulder<br>Orthopaedic implant for total shoulder replacement | Device: Delta Xtend Reverse Total Shoulder<br>* Orthopaedic implant for total shoulder replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total shoulder replacement, rotator cuff, osteoarthritis, rheumatoid arthritis, Delta Extend