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

NCT00737087 | Terminated

• 1 other identifier: CT0515
• Study Type: interventional
• Target: 144
• Locations: 3 countries
• Sites: 5

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

Keywords

total shoulder replacement; rotator cuff; osteoarthritis; rheumatoid arthritis; Delta Extend

Outcome Measures

Primary Outcomes (1)

• Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.

  2 years

Secondary Outcomes (2)

• 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

Study Arms (1)

Delta Xtend Reverse Total Shoulder

OTHER

Orthopaedic implant for total shoulder replacement

Device: Delta Xtend Reverse Total Shoulder

Interventions

Delta Xtend Reverse Total Shoulder DEVICE

Orthopaedic implant for total shoulder replacement

Delta Xtend Reverse Total Shoulder

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (5)

Universitair Ziekenhuis

Ghent, B-9000, Belgium

Location

Clinique Generale D'Annecy

Annecy, 74000, France

Location

CHRU Reims Hôpital Maison Blanche

Reims, 51092, France

Location

Polyclinique de l'Atlantique

Saint-Herblain, 44819, France

Location

Krankenhaus Munchen Bogenhausen

München, 81925, Germany

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy; Arthritis, Rheumatoid; Osteoarthritis

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: November 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: August 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-03

Locations

BE (1); FR (3); DE (1)