Rotator Cuff ArthropathyPhase 3RSPNCT00764504
Reverse Shoulder Prosthesis Study
A Phase 3 study testing Reverse Shoulder Prosthesis in people with Rotator Cuff Arthropathy and Failed Total Shoulder, run by Encore Medical, L.P. at 25 sites in United States.
Trial summary
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty
- What is being tested?
- Reverse Shoulder Prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 25 sitesUnited States
- Study dates
- Oct 2002to Aug 2008
- Phase
- Phase 3
- 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
Who may be able to join
- Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
- Evidence of upward displacement of the humeral head with respect to the glenoid
- Loss of glenohumeral joint space
- Functional deltoid muscle
- Patient is likely to be available for evaluation for the duration of the study
- Visual Analog Pain Scale 5 or greater
Who cannot join
- Non functional deltoid muscle
- Active sepsis
- Excessive glenoid bone loss
- Pregnancy
- Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
- Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
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- Prisoners
- Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
- Known metal allergy (i.e., jewelry).
- Visual Analog Pain Scale <5.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Crystal Clinic
Akron, Ohio, 44333
Study site
Atlanta, Georgia, 30342
Atlantis Orthopaedics
Atlantis, Florida, 33462
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Cincinnati Sports Medicine & Orthopaedic Center
Crestview, Kentucky, 41017
The Carrell Clinic
Dallas, Texas, 75231
Orthopedic Associates of Dallas
Dallas, Texas, 75246
University of Colorado
Denver, Colorado, 80054
Orthopedic Center of the Rockies
Fort Collins, Colorado, 80525
Orthopedic Specialty Associates, P.A.
Fort Worth, Texas, 76104
Arthritis Orthopedics and Sports Medicine
Glendale, California, 91206
Orthopaedic Surgery & Sports Medicine
Jupiter, Florida, 33458
Advanced Orthopedic and Sports Medicine Specialists, P.C.
Lonetree, Colorado, 80124
Study site
Lutherville, Maryland, 21093
Hospital for Special Surgery
New York, New York, 10021
Bone & Joint Hospital, LLC
Oklahoma City, Oklahoma, 73103
Orthopaedic Specialty Institute
Orange, California, 92868
Palm Beach Orthopaedic Institute
Palm Beach Gardens, Florida, 33410
Unlimited Research
San Antonio, Texas, 78217
Orthopedic Research Foundation of the Carolinas
Spartanburg, South Carolina, 29307
Florida Orthopedic Institute
Temple Terrace, Florida, 33637
Orthopedic Specialists
Towson, Maryland, 21204
Orthopedic Institute
Tyler, Texas, 75701
Steadman Hawkins SPT Medical Foundation
Vail, Colorado, 81657
About this study
Official title: Encore Reverse Shoulder Prosthesis
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.
- Being tested
- Reverse Shoulder Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Shoulder ProsthesisDevice
For subjects with rotator cuff arthropathy and no previous shoulder device implanted.
Reverse Shoulder ProsthesisDevice
For subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant.
| Study group | Role | What they receive |
|---|---|---|
| Primary | Experimental | Primary shoulder Receives: Device: Reverse Shoulder Prosthesis |
| Revision | Experimental | Revision shoulder Receives: Device: Reverse Shoulder Prosthesis |
| Continued Access | Experimental | Primary shoulder subjects enrolled at a later date in order to collect more data. Receives: Device: Reverse Shoulder Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons Shoulder Score
The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation:
[(10 - Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]
Measured: 2-year
Average Range of Motion
Physician's assessment of a subject's range of motion in degrees.
Measured: 2-year
Subject Satisfaction With Surgery
Each subject had a chance to rate their satisfaction with surgery at each study interval.
Measured: 2-year
Have Surgery Again?
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Measured: 2-year
Neer's "Limited Goals"
To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.
Measured: 2-year
Radiographic Failures
Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.
Measured: Post-operative, 3-month, 6-month, 1-year, 2-year
Safety Assessment
Number of device related adverse events and device failures at the 2 year time frame.
Measured: 2-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 startOct 2002
- Primary completionJun 2008
- Study completionAug 2008
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 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Frankle, M.D., Principal investigator, Florida Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764504
- Sponsor's protocol ID
- Study 300
- Acronym
- RSP
- Status last verified
- Mar 2011
- First submitted
- 30 Sep 2008
- Last updated
- 19 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encore Reverse Shoulder Prosthesis
- ClinicalTrials.gov ID
- NCT00764504
- Acronym / sponsor ID
- RSP / Study 300
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 19 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary | Experimental | Device: Reverse Shoulder ProsthesisPrimary shoulder |
| Revision | Experimental | Device: Reverse Shoulder ProsthesisRevision shoulder |
| Continued Access | Experimental | Device: Reverse Shoulder ProsthesisPrimary shoulder subjects enrolled at a later date in order to collect more data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
- Evidence of upward displacement of the humeral head with respect to the glenoid
- Loss of glenohumeral joint space
- Functional deltoid muscle
- Patient is likely to be available for evaluation for the duration of the study
Key exclusion criteria (10 listed)
- Non functional deltoid muscle
- Active sepsis
- Excessive glenoid bone loss
- Pregnancy
- Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
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 |
|---|---|---|
| Reverse Shoulder ProsthesisFor subjects with rotator cuff arthropathy and no previous shoulder device implanted. | Device | Continued Access, Primary |
| Reverse Shoulder ProsthesisFor subjects with rotator cuff arthropathy and a failed hemi or total shoulder implant. | Device | Revision |
Primary outcome
American Shoulder and Elbow Surgeons Shoulder Score
Time frame: 2-year
The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: [(10 - Visual analog scale pain score) x 5] + [(5/3) x Cumulative ADL score]
Average Range of Motion
Time frame: 2-year
Physician's assessment of a subject's range of motion in degrees.
Subject Satisfaction With Surgery
Time frame: 2-year
Each subject had a chance to rate their satisfaction with surgery at each study interval.
Have Surgery Again?
Time frame: 2-year
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Neer's "Limited Goals"
Time frame: 2-year
To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit >90 degrees active forward elevation and exhibit >20 degrees of active external rotation.
Radiographic Failures
Time frame: Post-operative, 3-month, 6-month, 1-year, 2-year
Radiographic failure is defined as a shift in the position of the component >3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a >2mm radiolucency completely around either prosthesis.
Safety Assessment
Time frame: 2-year
Number of device related adverse events and device failures at the 2 year time frame.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor company home pageLink provided by the sponsor.
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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.
Mark Frankle, M.D. principal investigator
Florida Orthopedic Institute
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Reverse Shoulder Prosthesis in people with Rotator Cuff Arthropathy and Failed Total Shoulder, run by Encore Medical, L.P. at 25 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 6 inclusion and 10 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2011). 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?
American Shoulder and Elbow Surgeons Shoulder Score (time frame: 2-year). The study lists 7 primary outcomes in all. 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 19 Apr 2011.