Glenohumeral Joint DegenerationNCT02768597
Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
A study testing ReUnion System with a Large-Diameter Glenosphere +2 mm offset, ReUnion System with a Small-Diameter Glenosphere +2 mm offset and ReUnion System with a Large-Diameter Glenosphere +6 mm offset in people with Glenohumeral Joint Degeneration, run by Mayo Clinic at 1 site in United States.
Trial summary
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Glenohumeral Joint Degeneration
- What is being tested?
- ReUnion System with a Large-Diameter Glenosphere +2 mm offset, ReUnion System with a Small-Diameter Glenosphere +2 mm offset and ReUnion System with a Large-Diameter Glenosphere +6 mm offset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 15 Dec 2022
- Phase
- Interventional
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects willing to sign the informed consent
- Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
- Subjects requiring a primary reverse total shoulder arthroplasty
- Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss
Who cannot join
- Inability to comply with follow-up requirements
- Subjects with inflammatory arthritis
- Subjects with proximal humerus fractures
- Subjects with sequels of trauma
- Subjects that are immunologically compromised
- Subjects with an active or suspected latent infection in or about the shoulder
Show all 9Show fewer
- Need to add a tendon transfer
- Need for structural humeral bone graft
- Pregnant subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.
- Conditions
- Glenohumeral Joint Degeneration
- Being tested
- ReUnion System with a Large-Diameter Glenosphere +2 mm offset, ReUnion System with a Small-Diameter Glenosphere +2 mm offset, ReUnion System with a Large-Diameter Glenosphere +6 mm offset, ReUnion System with a Small-Diameter Glenosphere +6 mm offset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReUnion System with a Large-Diameter Glenosphere +2 mm offsetDevice
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
ReUnion System with a Small-Diameter Glenosphere +2 mm offsetDevice
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
ReUnion System with a Large-Diameter Glenosphere +6 mm offsetDevice
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
ReUnion System with a Small-Diameter Glenosphere +6 mm offsetDevice
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
| Study group | Role | What they receive |
|---|---|---|
| Large-Diameter Glenosphere +2 mm offset | Active comparator | Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset Receives: Device: ReUnion System with a Large-Diameter Glenosphere +2 mm offset |
| Small-Diameter Glenosphere +2 mm offset | Active comparator | Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset Receives: Device: ReUnion System with a Small-Diameter Glenosphere +2 mm offset |
| Large-Diameter Glenosphere +6 mm offset | Active comparator | Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset Receives: Device: ReUnion System with a Large-Diameter Glenosphere +6 mm offset |
| Small-Diameter Glenosphere +6 mm offset | Active comparator | Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset Receives: Device: ReUnion System with a Small-Diameter Glenosphere +6 mm offset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Forward Elevation of the Shoulder
Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees.
Measured: One year
Active External Rotation of the Shoulder
Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees.
Measured: One year
Shoulder Abduction Strength
Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Measured: one year
Shoulder External Rotation Strength
Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Measured: One year
Shoulder Internal Rotation Strength
Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Measured: One year
Secondary outcomes (5)
Oxford Shoulder Score (OSS) Questionnaire
The Oxford Shoulder Score (OSS) is a patient reported questionnaire that includes 12 descriptors of pain and disability for shoulder ailments and related quality of daily activities. Each descriptor rating ranges from 0 to 4, with 4 representing the best (no pain, no difficulty with activity) and 0 is the worst (unbearable pain, extreme difficulty with activity). The score is calculated from the summation of all 12 descriptors, for a total range of 0 to 48, where a higher score reflects the best outcome (less pain and difficulty with activity) and a lower score reflects a worse outcome (more pain and difficulty with activity).
Measured: 1 year
American Shoulder and Elbow Surgeons (ASES) Questionnaire
A self-assessment that measures pain and ability to perform daily activities.The questionnaire is divided into 2 components, a single pain question and 10 questions on function of daily living.The total score is weighted 50% for pain and 50% for function. Pain is ranked from 0-10, where 0 is no pain and 10 is unbearable pain.The total pain score is calculated by subtracting the result of this question from 10 and multiplying by 5.The function score is calculated from the sum of 10 questions on daily living.The 10 questions are scored from 0-3, where 0=unable to perform daily activity and 3=no difficulty with daily activity.The individual function scores are summed for a maximum functional score of 30.This functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points.The pain and function scores are then added together to obtain the final score out of 100.The final score ranges from 0 to 100, where higher scores correlate to better outcomes.
Measured: One year
Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire
The Quick DASH (disabilities of the arm, shoulder and hand) questionnaire is an 11 item self-reported participant questionnaire that measures physical function and symptoms in individuals experiencing musculoskeletal disorders of the upper limb. Each item is scored 1-5 where 1 reflects no pain or difficulty with activities and 5 reflects extreme pain or difficulty with activities. All individual scores are then summed and averaged to produce a score out of five. The score is then transformed to a score out of 100 by subtracting one and multiplying by 25. The final score ranges from 0 to 100, where a higher resulting score reflects more pain and greater disability while a lower score reflects less pain and disability.
Measured: One year
Shoulder Pain
Shoulder pain values reported by participants will be assessed using the 10cm Visual Analogue Scale (VAS). The VAS line will be 10 cm long with two endpoints representing 0 (no pain) and 10 (worst possible pain). Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of centimeters will be reported as the pain score.
Measured: One year
Patient Satisfaction
Patient satisfaction with the outcome of the surgery measured by on a scale from 1-10, where 1 is not at all satisfied and 10 is very satisfied.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2016
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
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 Glenohumeral Joint DegenerationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Mark E. Morrey, M.D., Mayo Clinic
- Investigators
- Mark Morrey, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768597
- Sponsor's protocol ID
- 15-006839
- Status last verified
- Jan 2024
- First submitted
- 20 Apr 2016
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System
- ClinicalTrials.gov ID
- NCT02768597
- Acronym / sponsor ID
- 15-006839
- Conditions
- Glenohumeral Joint Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- Apr 2016
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Large-Diameter Glenosphere +2 mm offset | Active comparator | Device: ReUnion System with a Large-Diameter Glenosphere +2 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset |
| Small-Diameter Glenosphere +2 mm offset | Active comparator | Device: ReUnion System with a Small-Diameter Glenosphere +2 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset |
| Large-Diameter Glenosphere +6 mm offset | Active comparator | Device: ReUnion System with a Large-Diameter Glenosphere +6 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset |
| Small-Diameter Glenosphere +6 mm offset | Active comparator | Device: ReUnion System with a Small-Diameter Glenosphere +6 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects willing to sign the informed consent
- Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
- Subjects requiring a primary reverse total shoulder arthroplasty
- Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss
Key exclusion criteria (9 listed)
- Inability to comply with follow-up requirements
- Subjects with inflammatory arthritis
- Subjects with proximal humerus fractures
- Subjects with sequels of trauma
- Subjects that are immunologically compromised
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 |
|---|---|---|
| ReUnion System with a Large-Diameter Glenosphere +2 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset | Device | Large-Diameter Glenosphere +2 mm offset |
| ReUnion System with a Small-Diameter Glenosphere +2 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset | Device | Small-Diameter Glenosphere +2 mm offset |
| ReUnion System with a Large-Diameter Glenosphere +6 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset | Device | Large-Diameter Glenosphere +6 mm offset |
| ReUnion System with a Small-Diameter Glenosphere +6 mm offsetPrimary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset | Device | Small-Diameter Glenosphere +6 mm offset |
Primary outcome
Active Forward Elevation of the Shoulder
Time frame: One year
Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees.
Active External Rotation of the Shoulder
Time frame: One year
Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees.
Shoulder Abduction Strength
Time frame: one year
Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Shoulder External Rotation Strength
Time frame: One year
Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Shoulder Internal Rotation Strength
Time frame: One year
Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
5 secondary outcomes
Oxford Shoulder Score (OSS) Questionnaire
Time frame: 1 year
American Shoulder and Elbow Surgeons (ASES) Questionnaire
Time frame: One year
Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire
Time frame: One year
Shoulder Pain
Time frame: One year
Patient Satisfaction
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Glenohumeral Joint Degeneration
Recruiting
Migration and Functional Outcome of DELTA Xtend Reverse Shoulder Lateralized Glenosphere Line Extension System
Rotator Cuff Arthropathy or Degeneration of the Glenohumeral Joint with Severe Posterior Wear
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 Morrey, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReUnion System with a Large-Diameter Glenosphere +2 mm offset, ReUnion System with a Small-Diameter Glenosphere +2 mm offset and ReUnion System with a Large-Diameter Glenosphere +6 mm offset in people with Glenohumeral Joint Degeneration, run by Mayo Clinic 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 4 inclusion and 9 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 13 Feb 2024. 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 13 Feb 2024). 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?
Active Forward Elevation of the Shoulder (time frame: One year). The study lists 5 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 13 Feb 2024.