Cuff Tear ArthropathyNCT00737087
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
A study testing Delta Xtend Reverse Total Shoulder in people with Cuff Tear Arthropathy and Osteoarthritis With Cuff Deficiency, run by DePuy International at 5 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Rheumatoid Arthritis
- What is being tested?
- Delta Xtend Reverse Total Shoulder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Nov 2007to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
France3 sites
Clinique Generale D'Annecy
Annecy, 74000
CHRU Reims Hôpital Maison Blanche
Reims, 51092
Polyclinique de l'Atlantique
Saint-Herblain, 44819
About this study
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.
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
- Being tested
- Delta Xtend Reverse Total Shoulder
- Keywords
- total shoulder replacement, rotator cuff, osteoarthritis, rheumatoid arthritis, Delta Extend
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Arthritis, Rheumatoid, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta Xtend Reverse Total ShoulderDevice
Orthopaedic implant for total shoulder replacement
| Study group | Role | What they receive |
|---|---|---|
| Delta Xtend Reverse Total Shoulder | Other | Orthopaedic implant for total shoulder replacement Receives: Device: Delta Xtend Reverse Total Shoulder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.
Measured: 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.
Measured: 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.
Measured: 1, 2, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2013
- Study completionAug 2015
Why it stopped: Study was stopped due to low follow-up compliance at study sites.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Tear ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- DePuy International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737087
- Sponsor's protocol ID
- CT0515
- Status last verified
- Mar 2016
- First submitted
- 15 Aug 2008
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00737087
- Acronym / sponsor ID
- CT0515
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to low follow-up compliance at study sites.
- Enrolment
- 144 participants (actual)
- Lead sponsor
- DePuy InternationalIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delta Xtend Reverse Total Shoulder | Other | Device: Delta Xtend Reverse Total ShoulderOrthopaedic implant for total shoulder replacement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delta Xtend Reverse Total ShoulderOrthopaedic implant for total shoulder replacement | Device | Delta Xtend Reverse Total Shoulder |
Primary outcome
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results.
Time frame: 2 years
2 secondary outcomes
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.
Time frame: 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.
Time frame: 1, 2, 5 and 10 years
Results and safety
The study was stopped early (reason given: Study was stopped due to low follow-up compliance at study sites.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delta Xtend Reverse Total Shoulder in people with Cuff Tear Arthropathy and Osteoarthritis With Cuff Deficiency, run by DePuy International at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to low follow-up compliance at study sites.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative functionality through a difference in Constant Score post-treatment, as compared with pre-treatment results. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.