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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00737087
Date of registration: 15/08/2008
Primary sponsor: DePuy International
Public title: Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
Scientific 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.
Date of first enrolment: October 2007
Target sample size: 250
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00737087
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Belgium France Germany Sweden
Contacts
Name:   Anders Ekelund
Address: 
Telephone:
Email:
Affiliation:  St Görans Hospital, Stockholm, Sweden
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Cuff Tear Arthropathy
Osteoarthritis With Cuff Deficiency
Post Traumatic Injury to Shoulder
Revision Surgery of a Failed Anatomic Shoulder Prosthesis
Rheumatoid Arthritis
Intervention(s)
Device: Delta Xtend Reverse Total Shoulder
Primary Outcome(s)
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. [Time Frame: 2 years]
Secondary Outcome(s)
Determine implant survivorship and surgical revision information at 1, 2, 5 and 10years via Kaplan-Meier survival analysis. [Time Frame: 10 years]
Postoperative functionality at 12weeks, 1, 2, 5 and 10years through a difference in the Constant score, ASES score, U-Penn score and EQ-5D as compared with pre-treatment scores. [Time Frame: 10 years]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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