Reverse Total Shoulder ArthroplastyNCT04807322
Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study
An observational study of Reverse Total Shoulder Arthroplasty, run by Bürgerspital Solothurn at 1 site in Switzerland.
Trial summary
Reverse total shoulder arthroplasty (RTSA) has become an established treatment for cuff arthropathy, severe osteoarthritis and in certain fracture cases. Due to the increasingly aging population, patients who have already exceeded their life-expectancy pose a significant challenge to the shoulder surgeon. Read more about this study
- Who is it for?
- Ages 83 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reverse Total Shoulder Arthroplasty
- What is being tested?
- Reverse Total Shoulder Arthroplasty (RTSA)
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Mar 2019to 21 Dec 2020
- Phase
- Observational
- 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 83 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients who have already exceeded their life-expectancy (83 years in Switzerland)
Who may be able to join
- Patients older than 83 years at time of surgery
- Patients who received a reverse total shoulder arthroplasty
Who cannot join
- Patients younger than 83 years at time of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Reverse total shoulder arthroplasty (RTSA) has become an established treatment for cuff arthropathy, severe osteoarthritis and in certain fracture cases. Due to the increasingly aging population, patients who have already exceeded their life-expectancy pose a significant challenge to the shoulder surgeon. Therefore, we wanted to investigate patient demographics, hospital stay length, complication rate functional outcome, patient reported outcome scores and mortality retrospectively for patients, who were older than 83 years at time of implantation of a RTSA.
Read the detailed description
This is a retrospective single institution study. All patients older than 83 years who received a reverse shoulder arthroplasty from 2008 until 2019 are included. Elective cases are compared to fracture cases (patient demographics, length of hospital stay, complication rate, functional outcome, patient reported outcome scores and mortality).
- Conditions
- Reverse Total Shoulder Arthroplasty
- Being tested
- Reverse Total Shoulder Arthroplasty (RTSA)
- Keywords
- reverse total shoulder arthroplasty, RTSA, elderly, proximal humerus fracture, cuff arthropathy, outcome, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reverse Total Shoulder Arthroplasty (RTSA)Procedure or surgery
Implantation of a Reverse Total Shoulder Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Elective cases | Patients, who received a RTSA for degenerative reasons like cuff arthropathy or osteoarthritis Receives: Procedure: Reverse Total Shoulder Arthroplasty (RTSA) | |
| Fracture cases | Patients, who received a RTSA for a proximal humerus fracture Receives: Procedure: Reverse Total Shoulder Arthroplasty (RTSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome score: ASES
American Shoulder and Elbow Society (ASES) Score
Measured: until august 2020
Complication rate
postoperative complications requiring surgical intervention
Measured: until august 2020
Quality adjusted life year (QALY)
The quality adjusted life year (QALY) ) is a well-established indicator of the life quality for the remaining years and was calculated as the years of life following the operation, multiplied by the utility value, for the current study, defined as the postoperative American Shoulder and Elbow Surgeons Shoulder Score (ASES) score (0-1 points) at last follow-up.
Measured: until august 2020
Mortality
Survivership
Measured: until august 2020
Patient reported outcome score: QuickDASH
Quick Disabilities of the arm, shoulder and hand (DASH) Score,
Measured: until august 2020
Patient reported outcome score: VAS
Visual analog score (VAS)
Measured: until august 2020
Secondary outcomes (1)
Patient demographics
male/female ratio, age, BMI, ASA (American Society of Anesthesiologists) classification, hospital stay length, range of motion
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start24 Mar 2019
- Primary completion4 Aug 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reverse 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bürgerspital Solothurn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Lan Dao Trong, Bürgerspital Solothurn
- Investigators
- Mai Lan Dao Trong, MD, Principal investigator, Bürgerspital Solothurn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807322
- Sponsor's protocol ID
- RTSA in very old patients
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 19 Mar 2021
- 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 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04807322
- Acronym / sponsor ID
- RTSA in very old patients
- Conditions
- Reverse Total Shoulder Arthroplasty
- Keywords
- reverse total shoulder arthroplasty, RTSA, elderly, proximal humerus fracture, cuff arthropathy, outcome, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bürgerspital SolothurnUniversity, hospital or other
- Study start
- 24 Mar 2019 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 19 Mar 2021 (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.
Reverse total shoulder arthroplasty (RTSA) has become an established treatment for cuff arthropathy, severe osteoarthritis and in certain fracture cases. Due to the increasingly aging population, patients who have already exceeded their life-expectancy pose a significant challenge to the shoulder surgeon. Therefore, we wanted to investigate patient demographics, hospital stay length, complication rate functional outcome, patient reported outcome scores and mortality retrospectively for patients, who were older than 83 years at time of implantation of a RTSA.
Detailed description
This is a retrospective single institution study. All patients older than 83 years who received a reverse shoulder arthroplasty from 2008 until 2019 are included. Elective cases are compared to fracture cases (patient demographics, length of hospital stay, complication rate, functional outcome, patient reported outcome scores and mortality).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective cases | – | Procedure: Reverse Total Shoulder Arthroplasty (RTSA)Patients, who received a RTSA for degenerative reasons like cuff arthropathy or osteoarthritis |
| Fracture cases | – | Procedure: Reverse Total Shoulder Arthroplasty (RTSA)Patients, who received a RTSA for a proximal humerus fracture |
Who may qualify
- Ages
- 83 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients who have already exceeded their life-expectancy (83 years in Switzerland)
Key inclusion criteria (2 listed)
- Patients older than 83 years at time of surgery
- Patients who received a reverse total shoulder arthroplasty
Key exclusion criteria (1 listed)
- Patients younger than 83 years at time of surgery
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 Total Shoulder Arthroplasty (RTSA)Implantation of a Reverse Total Shoulder Arthroplasty | Procedure or surgery | Elective cases, Fracture cases |
Primary outcome
Patient reported outcome score: ASES
Time frame: until august 2020
American Shoulder and Elbow Society (ASES) Score
Complication rate
Time frame: until august 2020
postoperative complications requiring surgical intervention
Quality adjusted life year (QALY)
Time frame: until august 2020
The quality adjusted life year (QALY) ) is a well-established indicator of the life quality for the remaining years and was calculated as the years of life following the operation, multiplied by the utility value, for the current study, defined as the postoperative American Shoulder and Elbow Surgeons Shoulder Score (ASES) score (0-1 points) at last follow-up.
Mortality
Time frame: until august 2020
Survivership
Patient reported outcome score: QuickDASH
Time frame: until august 2020
Quick Disabilities of the arm, shoulder and hand (DASH) Score,
Patient reported outcome score: VAS
Time frame: until august 2020
Visual analog score (VAS)
1 secondary outcome
Patient demographics
Time frame: at time of surgery
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 19 Mar 2021.
- 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.
Mai Lan Dao Trong, MD principal investigator
Bürgerspital Solothurn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reverse Total Shoulder Arthroplasty, run by Bürgerspital Solothurn at 1 site in Switzerland.
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 2 inclusion and 1 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 Mar 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 Switzerland. 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?
Patient reported outcome score: ASES (time frame: until august 2020). The study lists 6 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 Mar 2021.