Arthropathy ShoulderNCT03735173
Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
A study testing ReUnion TSA, pegged design and ReUnion TSA, keeled design in people with Arthropathy Shoulder and Shoulder Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthropathy Shoulder, Shoulder Pain, Shoulder Osteoarthritis
- What is being tested?
- ReUnion TSA, pegged design and ReUnion TSA, keeled design
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 7 May 2021
- Phase
- Interventional
- 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 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 female subjects ages 18 - 90 at the time of surgery
- Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)
Who cannot join
- Inability to comply with follow-up requirements
- Known or presumed substantial rotator cuff disorders
- Subjects with an active or suspected latent infection in or about the shoulder
- Subjects with instability (surgically or non-surgically addressed)
- Subjects presenting with posttraumatic avascular necrosis
- Need for glenoid bone grafting
- Pregnant subjects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
- Conditions
- Arthropathy Shoulder, Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions, Necrosis of Bone
- Being tested
- ReUnion TSA, pegged design, ReUnion TSA, keeled design
- Medical subject headings
- Shoulder Pain, Osteonecrosis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReUnion TSA, pegged designProcedure or surgery
ReUnion total shoulder arthroplasty system, pegged design
ReUnion TSA, keeled designProcedure or surgery
ReUnion total shoulder arthroplasty system, keeled design
| Study group | Role | What they receive |
|---|---|---|
| Pegged through SP | Active comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation. Receives: Procedure: ReUnion TSA, pegged design |
| Pegged through ST | Active comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation. Receives: Procedure: ReUnion TSA, pegged design |
| Keeled through SP | Active comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation. Receives: Procedure: ReUnion TSA, keeled design |
| Keeled through ST | Active comparator | Primary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation. Receives: Procedure: ReUnion TSA, keeled design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function of Subscapularis muscle as measured by belly-press test
Measured: 5 years
Radiographic loosening
"glenoid at risk" proportion
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Dec 2018
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy ShoulderStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark E. Morrey, M.D., Mayo Clinic
- Investigators
- Mark Morrey, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735173
- Sponsor's protocol ID
- 17-011251
- Status last verified
- Aug 2021
- First submitted
- 4 Oct 2018
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Outcome of Cemented All-Polyethylene Pegged vs. Keeled Components Through a Subscapularis Tenotomy or a Subscapularis Peel
- ClinicalTrials.gov ID
- NCT03735173
- Acronym / sponsor ID
- 17-011251
- Conditions
- Arthropathy Shoulder, Shoulder Pain, Shoulder Osteoarthritis, Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions, Necrosis of Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 8 Nov 2018 (actual)
- 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.
Participants who choose to participate in this study, will either have their tendon repaired to tendon, so-called tenotomy repair, or tendon repaired to bone, so-called peel repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pegged through SP | Active comparator | Procedure: ReUnion TSA, pegged designPrimary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through a Subscapularis Peel (SP) manipulation. |
| Pegged through ST | Active comparator | Procedure: ReUnion TSA, pegged designPrimary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene pegged glenoid component through subscapularis tenotomy (ST) manipulation. |
| Keeled through SP | Active comparator | Procedure: ReUnion TSA, keeled designPrimary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through a Subscapularis Peel (SP) manipulation. |
| Keeled through ST | Active comparator | Procedure: ReUnion TSA, keeled designPrimary anatomic shoulder arthroplasty with implantation of a cemented all-polyethylene keeled glenoid component through subscapularis tenotomy (ST) manipulation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects willing to sign the informed consent
- Male and female subjects ages 18 - 90 at the time of surgery
- Subjects indicated for an anatomic total shoulder arthroplasty (including primary glenohumeral osteoarthritis, avascular necrosis, and inflammatory arthritis)
Key exclusion criteria (7 listed)
- Inability to comply with follow-up requirements
- Known or presumed substantial rotator cuff disorders
- Subjects with an active or suspected latent infection in or about the shoulder
- Subjects with instability (surgically or non-surgically addressed)
- Subjects presenting with posttraumatic avascular necrosis
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 TSA, pegged designReUnion total shoulder arthroplasty system, pegged design | Procedure or surgery | Pegged through SP, Pegged through ST |
| ReUnion TSA, keeled designReUnion total shoulder arthroplasty system, keeled design | Procedure or surgery | Keeled through SP, Keeled through ST |
Primary outcome
Function of Subscapularis muscle as measured by belly-press test
Time frame: 5 years
Radiographic loosening
Time frame: 5 years
"glenoid at risk" proportion
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 12 Aug 2021.
- Mayo Clinic Clinical TrialsLink 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 Morrey, M.D. 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 TSA, pegged design and ReUnion TSA, keeled design in people with Arthropathy Shoulder and Shoulder Pain, 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 3 inclusion and 7 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 12 Aug 2021. 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?
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?
Function of Subscapularis muscle as measured by belly-press test (time frame: 5 years). The study lists 2 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 12 Aug 2021.