Rotator Cuff DeficiencyNCT01005446
Reverse Shoulder Prosthesis Prospective Multi-Center Study
An observational study of Rotator Cuff Deficiency and Shoulder Arthropathy, run by Encore Medical, L.P. at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Rotator Cuff Deficiency, Shoulder Arthropathy, Failed Shoulder Replacement
- What is being tested?
- Encore Reverse Shoulder Prosthesis (RSP®)
- Type of treatment
- Medical device
- How many people
- 245 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2009to Jun 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are 60 years of age or older at the time of consent and are suffering from a grossly rotator cuff deficient shoulder joints with severe arthropathy or have a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
Who may be able to join
- Subject must be a candidate for a total shoulder joint replacement
- Subject must be diagnosed with one or more of the following conditions:
- Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery
- Subject has a functional deltoid muscle
- Subject's joint must be anatomically and functionally suited to receive the selected implant
- Subject is 60 years of age or older (≥ 60 yrs of age) at time of consent
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- Subject is likely to be available for all study visits
- Subject is able and willing to sign the informed consent and follow study procedures
- Subject is not pregnant
Who cannot join
- Subject has a non-functional deltoid muscle
- Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject has high levels of physical activity (ex. competitive sports, heavy physical labor)
- Subject is pregnant
- Subject has an active infection or sepsis
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- Subject has loss of ligamentous structures
- Subject has a history of alcoholism or other addictions (current or past)
- Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
- Subject has severe glenoid bone loss
- Subject has known materials sensitivity (to metals)
- Subject is younger than 60 years of age (< 60 years of age) at consent
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Excelsior Orthopaedics
Amherst, New York, 14226
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, 34209
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
Cincinnati Sports Medicine and Orthopeadic Center
Cincinnati, Ohio, 45242
Geisinger Medical Center
Danville, Pennsylvania, 17822
Orthopaedic Institute at Holy Cross Hospital
Fort Lauderdale, Florida, 33334
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, 40241
Texas Center for Joint Replacement
Plano, Texas, 75093
Stanford University - Dept. of Orthopedics
Redwood City, California, 94063
Rimrock Orthopedics
St. George, Utah, 84790
About this study
Official title: PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis
The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).
Read the detailed description
Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.
- Being tested
- Encore Reverse Shoulder Prosthesis (RSP®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encore Reverse Shoulder Prosthesis (RSP®)Device
Also called RSP®
The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
| Study group | Role | What they receive |
|---|---|---|
| RSP Device | Post Market Study Receives: Device: Encore Reverse Shoulder Prosthesis (RSP®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
Measured: 2 year
Secondary outcomes (5)
Radiologic Success
Changes in radiolucency compared with Baseline
Measured: 5 year
Change in ASES score from Baseline
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
Measured: 5 year
SF36- (Short Form 36)Health Survey
Change from baseline using the SF36-Health Status. There are multiple scales for general health, pain and activities of daily living
Measured: 5 year
Change in Simple Shoulder Test from Baseline
Change in Simple Shoulder Test from Baseline. Twelve questions about pain and functionality with responses being yes or no
Measured: 5 year
Subject Satisfaction Survey
Patient Related Outcome of Device Satisfaction (score 1-5 with 1 = best and 5 = worst) Device satisfaction
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
- Investigators
- Samer S. Hasan, M.D., Principal investigator, Cincinnati Sports Medicine and Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005446
- Sponsor's protocol ID
- PS - 901
- Status last verified
- Mar 2021
- First submitted
- 30 Oct 2009
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis
- ClinicalTrials.gov ID
- NCT01005446
- Acronym / sponsor ID
- PS - 901
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Collaborators
- DJO Incorporated
- Study start
- Dec 2009
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Nov 2009 (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.
The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).
Detailed description
Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RSP Device | – | Device: Encore Reverse Shoulder Prosthesis (RSP®)Post Market Study |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are 60 years of age or older at the time of consent and are suffering from a grossly rotator cuff deficient shoulder joints with severe arthropathy or have a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
Key inclusion criteria (9 listed)
- Subject must be a candidate for a total shoulder joint replacement
- Subject must be diagnosed with one or more of the following conditions:
- Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery
- Subject has a functional deltoid muscle
- Subject's joint must be anatomically and functionally suited to receive the selected implant
Key exclusion criteria (12 listed)
- Subject has a non-functional deltoid muscle
- Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject has high levels of physical activity (ex. competitive sports, heavy physical labor)
- Subject is pregnant
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 Prosthesis (RSP®)Also: RSP®The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. | Device | RSP Device |
Primary outcome
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline
Time frame: 2 year
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.
5 secondary outcomes
Radiologic Success
Time frame: 5 year
Change in ASES score from Baseline
Time frame: 5 year
SF36- (Short Form 36)Health Survey
Time frame: 5 year
Change in Simple Shoulder Test from Baseline
Time frame: 5 year
Subject Satisfaction Survey
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Sponsor websiteLink 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.
Samer S. Hasan, M.D. principal investigator
Cincinnati Sports Medicine and Orthopaedic Center
10 sites 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 Shoulder Arthropathy, run by Encore Medical, L.P. at 10 sites 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 9 inclusion and 12 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline (time frame: 2 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 30 Mar 2021.