Clinical trial NCT00737087: Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 12weeks, 1, 2, 5 and 10 years
measure: Determine implant survivorship and surgical revision information at 1, 2, 5 and 10 years via Kaplan-Meier survival analysis.
timeFrame: 1, 2, 5 and 10 years
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Universitair Ziekenhuis
city: Annecy
country: France
facility: Clinique Generale D'Annecy
city: Reims
country: France
facility: CHRU Reims Hôpital Maison Blanche
city: St Herblain
country: France
facility: Polyclinique de l'Atlantique
city: Munchen
country: Germany
facility: Krankenhaus Munchen Bogenhausen
Study officials:
References: