Reverse Total Shoulder ArthroplastyNCT02014350
Outcomes Following Delta Xtend Reverse Shoulder System
An observational study of Reverse Total Shoulder Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reverse Total Shoulder Arthroplasty
- What is being tested?
- DePuy Delta Xtend Reverse TSA
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: patients who were implanted with the DePuy Delta Xtend Reverse Total Shoulder Arthoplasty between 2008-2012
Who may be able to join
- Patients whom were implanted with the DePuy Delta Xtend Reverse Total Shoulder System in the time frame indicated. Patients must be willing to sign the consent form and complete all follow-up visits.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.
- Conditions
- Reverse Total Shoulder Arthroplasty
- Being tested
- DePuy Delta Xtend Reverse TSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Delta Xtend Reverse TSADevice
| Study group | Role | What they receive |
|---|---|---|
| DePuy Delta Xtend RTSA | Not described Receives: Device: DePuy Delta Xtend Reverse TSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship
Measured: 10 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Primary completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse Total Shoulder ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014350
- Sponsor's protocol ID
- RI2013
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Following Delta Xtend Reverse Shoulder System
- ClinicalTrials.gov ID
- NCT02014350
- Acronym / sponsor ID
- RI2013
- Conditions
- Reverse Total Shoulder Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Primary completion
- Mar 2020 (estimated)
- First posted
- 18 Dec 2013 (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.
To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DePuy Delta Xtend RTSA | – | Device: DePuy Delta Xtend Reverse TSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who were implanted with the DePuy Delta Xtend Reverse Total Shoulder Arthoplasty between 2008-2012
Key inclusion criteria (1 listed)
- Patients whom were implanted with the DePuy Delta Xtend Reverse Total Shoulder System in the time frame indicated. Patients must be willing to sign the consent form and complete all follow-up visits.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DePuy Delta Xtend Reverse TSA | Device | DePuy Delta Xtend RTSA |
Primary outcome
Implant Survivorship
Time frame: 10 years post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reverse Total Shoulder Arthroplasty, run by Rothman Institute Orthopaedics at 1 site in United States.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
Implant Survivorship (time frame: 10 years post-operative). 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 18 Dec 2013; AzTrials last refreshed its copy on 31 Oct 2026.