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

March 17, 2021 updated by: Mai Lan Dao Trong, Bürgerspital Solothurn
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Solothurn, Switzerland, 4500
        • Bürgerspital Solothurn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

83 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients younger than 83 years at time of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elective cases
Patients, who received a RTSA for degenerative reasons like cuff arthropathy or osteoarthritis
Implantation of a Reverse Total Shoulder Arthroplasty
Fracture cases
Patients, who received a RTSA for a proximal humerus fracture
Implantation of a Reverse Total Shoulder Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcome score: ASES
Time Frame: until august 2020
American Shoulder and Elbow Society (ASES) Score
until august 2020
Complication rate
Time Frame: until august 2020
postoperative complications requiring surgical intervention
until august 2020
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.
until august 2020
Mortality
Time Frame: until august 2020
Survivership
until august 2020
Patient reported outcome score: QuickDASH
Time Frame: until august 2020
Quick Disabilities of the arm, shoulder and hand (DASH) Score,
until august 2020
Patient reported outcome score: VAS
Time Frame: until august 2020
Visual analog score (VAS)
until august 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient demographics
Time Frame: at time of surgery
male/female ratio, age, BMI, ASA (American Society of Anesthesiologists) classification, hospital stay length, range of motion
at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mai Lan Dao Trong, MD, Bürgerspital Solothurn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2019

Primary Completion (Actual)

August 4, 2020

Study Completion (Actual)

December 21, 2020

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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