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

NCT ID: NCT00737087

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Delta Xtend Reverse Total Shoulder

Orthopaedic implant for total shoulder replacement

Group Type: OTHER

Delta Xtend Reverse Total Shoulder

Intervention Type: DEVICE

Orthopaedic implant for total shoulder replacement

Interventions

Delta Xtend Reverse Total Shoulder

Orthopaedic implant for total shoulder replacement

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

München, , Germany

Countries

Belgium; France; Germany

Other Identifiers

CT0515

Identifier Type: -

Identifier Source: org_study_id