Outcomes Assessments, PatientsNCT04405947
Influenze of Approach in Reversed Shoulder Prosthesis
A study testing Reverse Shoulder Arthroplasty in people with Outcomes Assessments, Patients and Rotator Cuff Arthropathy, run by Hospital del Mar.
Trial summary
To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Outcomes Assessments, Patients, Rotator Cuff Arthropathy
- What is being tested?
- Reverse Shoulder Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2016to 29 Oct 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
- Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
- No previous surgeries of the affected shoulder
- Acceptance by the patient to participate in the study
Who cannot join
- Fractures> 2 weeks of evolution
- Previous surgeries on the affected shoulder
- Not signing the informed consent
- Cognitive impairment
- Institutionalization of the patient
About this study
Official title: Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach
To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.
Read the detailed description
Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.
- Being tested
- Reverse Shoulder Arthroplasty
- Keywords
- reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Shoulder ArthroplastyProcedure or surgery
implantation of a reversed shoulder prostheses through two different surgical approaches
| Study group | Role | What they receive |
|---|---|---|
| deltopectoral | Other | deltopectoral surgical approach Receives: Procedure: Reverse Shoulder Arthroplasty |
| antero-superior | Other | antero-superior approach Receives: Procedure: Reverse Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
positioning of the metaglene of the reverse shoulder prostheses
to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
Measured: 2 years
Secondary outcomes (2)
scapular notch
determine scapular notch development in both approaches as determined with the aid of an AP X-ray view of the shoulder and thus classifying the scapular notch development according to Sirveaux et al. classification system.
Measured: 2 years
functional outcome
determine the functional outcome as measured with the Constant Score at 2-years follow-up
Measured: 2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start13 Jan 2016
- Primary completion18 Jan 2018
- Study completion29 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcomes Assessments, PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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
- NCT04405947
- Sponsor's protocol ID
- 2015/7913/I
- Status last verified
- Mar 2021
- First submitted
- 20 May 2020
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Randomized Prospective Study Comparing Reversed Shoulder Prosthesis Through the Superior Anterior Approach and the Deltopectoral Approach
- ClinicalTrials.gov ID
- NCT04405947
- Acronym / sponsor ID
- 2015/7913/I
- Keywords
- reverse shoulder arthroplasty, scapular notch, deltopectoral, anterosuperior approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 28 May 2020 (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.
To determine the differences in the placement of the glenoid implant of the inverted prostheses when they are implanted using a superior approach and using an anterior approach.
Detailed description
Inverted prostheses have proven to be effective in the treatment of all those pathologies that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures, sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous complications have been described after the use of inverted prostheses, such as glenoid erosion, infections, dislocation, or aseptic loosening. The most frequent complication related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of cases. This complication appears early in the evolution, usually before 2 years after surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option is to place the glenoid component low, so that if the glenoid component is flush with the lower margin of the glena, the chances of developing glenoid erosion are significantly reduced. Two types of approaches have been used to implant these prostheses, the deltopectoral and the superior anterior approach. Each of them has its advantages and disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors the best placement of the glenoid component, but sacrifices the subscapularis tendon, increasing the risk of dislocation of the components. On the contrary, the superior anterior approach respects the subscapularis tendon, reducing the risk of dislocation of the components but gives worse surgical exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| deltopectoral | Other | Procedure: Reverse Shoulder Arthroplastydeltopectoral surgical approach |
| antero-superior | Other | Procedure: Reverse Shoulder Arthroplastyantero-superior approach |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with secondary osteoarthritis of the shoulder who are candidates for an inverted prosthesis
- Acute fractures <2 weeks of evolution in patients candidates for inverted prostheses
- No previous surgeries of the affected shoulder
- Acceptance by the patient to participate in the study
Key exclusion criteria (5 listed)
- Fractures> 2 weeks of evolution
- Previous surgeries on the affected shoulder
- Not signing the informed consent
- Cognitive impairment
- Institutionalization of the patient
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 Arthroplastyimplantation of a reversed shoulder prostheses through two different surgical approaches | Procedure or surgery | antero-superior, deltopectoral |
Primary outcome
positioning of the metaglene of the reverse shoulder prostheses
Time frame: 2 years
to determine the metaglene postioning in both surgical approaches by measuring the distance between the inferior part of the metaglene and the glenoid inferior rim. The measurement will be done in an AP X-ray view of the shoulder and with the help of the measure tool in the PACS system of viewing.
2 secondary outcomes
scapular notch
Time frame: 2 years
functional outcome
Time frame: 2 years. The minimum value of the Constant Score is 0 and the maximum is 100. The higher scores mean a better outcome.
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.
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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 Outcomes Assessments, Patients and Rotator Cuff Arthropathy, 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 4 inclusion and 5 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.
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?
positioning of the metaglene of the reverse shoulder prostheses (time frame: 2 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 30 Mar 2021.