Rheumatoid Arthritis Clinical Trial
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.
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.
Status | Terminated |
Enrollment | 144 |
Est. completion date | August 2015 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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 XtendĂ” 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis | Gent | |
France | Clinique Generale D'Annecy | Annecy | |
France | CHRU Reims Hôpital Maison Blanche | Reims | |
France | Polyclinique de l'Atlantique | St Herblain | |
Germany | Krankenhaus Munchen Bogenhausen | Munchen |
Lead Sponsor | Collaborator |
---|---|
DePuy International |
Belgium, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. | 2 years | No | |
Secondary | 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 | No | |
Secondary | 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 | Yes |
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