- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04807322
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
Status
Completed
Conditions
Intervention / Treatment
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
-
-
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Solothurn, Switzerland, 4500
- Bürgerspital Solothurn
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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.
Sponsor
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
Keywords
Other Study ID Numbers
- RTSA in very old patients
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.
Clinical Trials on Reverse Total Shoulder Arthroplasty
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Rothman Institute OrthopaedicsUnknownReverse Total Shoulder ArthroplastyUnited States
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Campbell ClinicAmerican Shoulder and Elbow SurgeonsEnrolling by invitationStudy of Zimmer Biomet Mymobility Application on Reverse Total Shoulder Arthroplasty (RTSA) OutcomesPhysical Therapy | Reverse Total Shoulder ArthroplastyUnited States
-
Rush University Medical CenterCompletedBlood Loss | Transfusion | Tranexamic Acid | Reverse Total Shoulder Arthroplasty | Anatomic Total Shoulder ArthroplastyUnited States
-
Johnny K. LeeNorthShore University HealthSystemRecruitingTotal Shoulder Arthroplasty | Reverse Total Shoulder ArthroplastyUnited States
-
The Cooper Health SystemRecruitingProximal Humeral Fracture | Reverse Total Shoulder ArthroplastyUnited States
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University of FloridaActive, not recruitingPrimary Anatomic or Reverse Total Shoulder ArthroplastyUnited States
-
St. Louis Joint Replacement InstituteUnknownReverse or Primary Total Shoulder | Rotator Cuff- Full Thickness- RepairUnited States
-
University of MinnesotaRecruitingTotal Shoulder ArthroplastyUnited States
-
The Cleveland ClinicCompletedTotal Shoulder ArthroplastyUnited States
-
Hospital for Special Surgery, New YorkCompleted
Clinical Trials on Reverse Total Shoulder Arthroplasty (RTSA)
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University of AlbertaCanadian Orthopaedic Foundation; University Hospital FoundationRecruitingShoulder OsteoarthritisCanada
-
Ottawa Hospital Research InstituteRecruiting
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Washington University School of MedicineZimmer BiometTerminated
-
Mayo ClinicTerminatedShoulder Fractures | Arthropathy | Humerus Fracture | Shoulder Injury | Shoulder Arthropathy Associated With Other Conditions | Arthropathy Shoulder | HumerusUnited States
-
The Orthopaedic Research & Innovation FoundationUnknownRotator Cuff Tear | Proximal Humeral Fracture | Osteo Arthritis Shoulders | Rotator Cuff Tear ArthropathyUnited States
-
Ottawa Hospital Research InstituteRecruitingOsteoarthritis ShoulderCanada
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Stryker Trauma GmbHTerminatedArthroplasty | Hemiarthroplasty | Shoulder PainUnited States
-
Signe Rosner RasmussenHerlev and Gentofte HospitalNot yet recruiting
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Karolinska InstitutetCompleted
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Oslo University HospitalDiakonhjemmet Hospital; Sykehuset Telemark; Helse Forde; Sykehuset Ostfold; Sykehuset... and other collaboratorsCompletedProximal Humeral Fractures, AO/OTA (2007) Group B2 and C2Norway