Rotator Cuff DeficiencyNCT00765037
Retrospective Encore Reverse Shoulder Prosthesis Study
An observational study of Rotator Cuff Deficiency and Glenohumeral Arthritis, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Deficiency, Glenohumeral Arthritis
- What is being tested?
- Encore Reverse Shoulder Prosthesis
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria
Who may be able to join
- The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
- The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
- The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Who cannot join
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant, as determined by the physician
- Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
- Alcoholism or other addictions
- Materials (metals, etc) sensitivity
- Loss of ligamentous structures
- High levels of physical activity
- Non-functional deltoid muscle
Trial locations and contacts
1 site in 1 country.
United States1 site
Nashville Orthopedic Specialists
Nashville, Tennessee, 37203
About this study
Official title: Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.
- Conditions
- Rotator Cuff Deficiency, Glenohumeral Arthritis
- Being tested
- Encore Reverse Shoulder Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore Reverse Shoulder ProsthesisDevice
rotator cuff deficiency and glenohumeral arthritis
| Study group | Role | What they receive |
|---|---|---|
| Encore RSP | Subjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study. Receives: Device: Encore Reverse Shoulder Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of the Encore Reverse Shoulder Prosthesis
Number of subjects who completed all study visits through the 1 year visit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff DeficiencyStudies 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
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Michael Kioschos, M.D., Principal investigator, Nashville Orthopedic Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765037
- Sponsor's protocol ID
- PS - 902
- Status last verified
- Aug 2010
- First submitted
- 30 Sep 2008
- Last updated
- 25 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects
- ClinicalTrials.gov ID
- NCT00765037
- Acronym / sponsor ID
- PS - 902
- Conditions
- Rotator Cuff Deficiency, Glenohumeral Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 25 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Encore RSP | – | Device: Encore Reverse Shoulder ProsthesisSubjects who need treatment for rotator cuff deficiency or glenohumeral arthritis, received the Encore Reverse Shoulder Prosthesis and are willing to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who meet the indications for use of the RSP device AND who meet the inclusion/exclusion criteria
Key inclusion criteria (3 listed)
- The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
- The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
- The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.
Key exclusion criteria (8 listed)
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant, as determined by the physician
- Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
- Alcoholism or other addictions
- Materials (metals, etc) sensitivity
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 |
|---|---|---|
| Encore Reverse Shoulder Prosthesisrotator cuff deficiency and glenohumeral arthritis | Device | Encore RSP |
Primary outcome
Survivorship of the Encore Reverse Shoulder Prosthesis
Time frame: 1 year
Number of subjects who completed all study visits through the 1 year visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor Company home pageLink provided by the sponsor.
Related trials for Rotator Cuff Deficiency
Active, not recruiting
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Not yet recruitingObservational study
Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty
Rotator Cuff Injuries, Shoulder Fractures
Active, not recruitingObservational study
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
Osteoarthritis, Rheumatoid Arthritis
Enrolling by invitationObservational study
Comprehensive Reverse Shoulder Data Collection
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Enrolling by invitation
The Influence of Repairing the Sub-scapularis on Outcomes After Reverse Arthroplasty
Severe Arthropathy With a Grossly Deficient Rotator Cuff
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.
J. Michael Kioschos, M.D. principal investigator
Nashville Orthopedic Specialists
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 Rotator Cuff Deficiency and Glenohumeral Arthritis, run by Encore Medical, L.P. 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 25 Aug 2010. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Survivorship of the Encore Reverse Shoulder Prosthesis (time frame: 1 year). 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 25 Aug 2010.