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CompletedNCT04807322Updated Mar 19, 2021

Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study

An observational study in Reverse Total Shoulder Arthroplasty, sponsored by Bürgerspital Solothurn. Completed at 1 site in Switzerland. Open to participants aged 83 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Bürgerspital Solothurn · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
110
Ages
83 Years and older
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Reverse Total Shoulder Arthroplasty

Keywords

  • reverse total shoulder arthroplasty
  • RTSA
  • elderly
  • proximal humerus fracture
  • cuff arthropathy
  • outcome
  • complications
03

In context

Lead sponsor

Bürgerspital Solothurn is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
83 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients who have already exceeded their life-expectancy (83 years in Switzerland)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients older than 83 years at time of surgery
  • Patients who received a reverse total shoulder arthroplasty

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 83 years at time of surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
110 participants (actual)
Patient registry
No

Groups and cohorts

  • Elective cases

    Patients, who received a RTSA for degenerative reasons like cuff arthropathy or osteoarthritis

    Procedure: Reverse Total Shoulder Arthroplasty (RTSA)

  • Fracture cases

    Patients, who received a RTSA for a proximal humerus fracture

    Procedure: Reverse Total Shoulder Arthroplasty (RTSA)

Interventions

  • ProcedureReverse Total Shoulder Arthroplasty (RTSA)

    Implantation of a Reverse Total Shoulder Arthroplasty

06

What researchers measure

Primary outcomes

  1. Patient reported outcome score: ASES

    American Shoulder and Elbow Society (ASES) Score

    Time frame: until august 2020

  2. Complication rate

    postoperative complications requiring surgical intervention

    Time frame: until august 2020

  3. 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.

    Time frame: until august 2020

  4. Mortality

    Survivership

    Time frame: until august 2020

  5. Patient reported outcome score: QuickDASH

    Quick Disabilities of the arm, shoulder and hand (DASH) Score,

    Time frame: until august 2020

  6. Patient reported outcome score: VAS

    Visual analog score (VAS)

    Time frame: 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

    Time frame: at time of surgery

07

Study locations

1 site
  • Bürgerspital Solothurn
    Solothurn, 4500, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in Aug 2020, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2021
First posted
Mar 19, 2021
StartActual
Mar 24, 2019
Primary completionActual
Aug 4, 2020
CompletionActual
Dec 21, 2020
Last update
Mar 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04807322
Lead sponsor
Bürgerspital Solothurn
Responsible party
Mai Lan Dao Trong (Attending physician shoulder and elbow surgery, Bürgerspital Solothurn) — Principal investigator
First posted
Mar 19, 2021
Start date
Mar 24, 2019
Primary completion
Aug 4, 2020
Completion
Dec 21, 2020
Last update
Mar 19, 2021

Study contacts

Mai Lan Dao Trong, MD
principal investigator · Bürgerspital Solothurn

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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