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

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737087
• Other study ID #: CT0515
• Status: Terminated
• Phase: N/A
• First received: August 15, 2008
• Last updated: April 20, 2016
• Start date: November 2007
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardSweden: Institutional Review BoardFrance: Institutional Ethical CommitteeGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Delta Xtend Reverse Total Shoulder
Orthopaedic implant for total shoulder replacement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

Outcome

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