Total Shoulder ArthroplastyGSSNRSANCT03730597
Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study
A study testing reverse shoulder arthroplasty in people with Total Shoulder Arthroplasty, run by Hospital del Mar.
Trial summary
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Shoulder Arthroplasty
- What is being tested?
- reverse shoulder arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 9 Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures
Who cannot join
- patients with previous surgery
- patients with deltoid deficiency
- patients with acute infection
About this study
Official title: Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.
- Conditions
- Total Shoulder Arthroplasty
- Being tested
- reverse shoulder arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse shoulder arthroplastyDevice
Also called Delta X-tend
prosthesis implantation
| Study group | Role | What they receive |
|---|---|---|
| glenosphere 42 | Active comparator | patients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch Receives: Device: reverse shoulder arthroplasty |
| glenosphere 38 ECC | Active comparator | patients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch Receives: Device: reverse shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
scapular notch development
X-ray assessment of scapular notch development
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Sep 2014
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Shoulder ArthroplastyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Torrens, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730597
- Sponsor's protocol ID
- Torrens.00
- Other IDs
- CTorrens
- Acronym
- GSSNRSA
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenze of Glenosphere Size in Scapular Notch Development. Randomized Study Comparing 42 to 38 ECC
- ClinicalTrials.gov ID
- NCT03730597
- Acronym / sponsor ID
- GSSNRSA / Torrens.00
- Conditions
- Total Shoulder Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 5 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.
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase. To improve that situation, eccentricity has been added to some glenospheres to increase glenoid overhanging. The objective is to assess if eccentricity can avoid scapular notch as effectively as bigger glenospheres.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized study
| Arm | Type | Receives |
|---|---|---|
| glenosphere 42 | Active comparator | Device: reverse shoulder arthroplastypatients receiving a reverse shoulder arthroplasty with a glenosphere sized 42. reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch |
| glenosphere 38 ECC | Active comparator | Device: reverse shoulder arthroplastypatients receiving a reverse shoulder arthroplasty with a glenosphere sized 38 ECC reverse shoulder prosthesis implantation X-Ray analysis to detect scapular notch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing reverse shoulder prosthesis because of rotator cuff disordes andacute fractures
Key exclusion criteria (3 listed)
- patients with previous surgery
- patients with deltoid deficiency
- patients with acute infection
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 arthroplastyAlso: Delta X-tendprosthesis implantation | Device | glenosphere 38 ECC, glenosphere 42 |
Primary outcome
scapular notch development
Time frame: two years
X-ray assessment of scapular notch development
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 Mar 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing reverse shoulder arthroplasty in people with Total Shoulder Arthroplasty, run by Hospital del Mar.
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 1 inclusion and 3 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
scapular notch development (time frame: two years). 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 Mar 2019.