Status:
TERMINATED
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
Lead Sponsor:
DePuy International
Conditions:
Cuff Tear Arthropathy
Osteoarthritis With Cuff Deficiency
Eligibility:
All Genders
18-85 years
Phase:
NA
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 mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00737087
Start Date
November 1 2007
End Date
August 1 2015
Last Update
April 21 2016
Active Locations (5)
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1
Universitair Ziekenhuis
Ghent, Belgium, B-9000
2
Clinique Generale D'Annecy
Annecy, France, 74000
3
CHRU Reims Hôpital Maison Blanche
Reims, France, 51092
4
Polyclinique de l'Atlantique
Saint-Herblain, France, 44819