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

Reverse Total Shoulder Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807322
• Other study ID #: RTSA in very old patients
• Status: Completed
• Start date: March 24, 2019
• Est. completion date: December 21, 2020

Study information

• Verified date: March 2021
• Source: Bürgerspital Solothurn
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 21, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 83 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Reverse Total Shoulder Arthroplasty

Intervention

Procedure:
• Reverse Total Shoulder Arthroplasty (RTSA)
Implantation of a Reverse Total Shoulder Arthroplasty

Locations

Country	Name	City	State
Switzerland	Bürgerspital Solothurn	Solothurn

Sponsors (1)

Lead Sponsor	Collaborator
Bürgerspital Solothurn

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcome score: ASES	American Shoulder and Elbow Society (ASES) Score	until august 2020
Primary	Complication rate	postoperative complications requiring surgical intervention	until august 2020
Primary	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.	until august 2020
Primary	Mortality	Survivership	until august 2020
Primary	Patient reported outcome score: QuickDASH	Quick Disabilities of the arm, shoulder and hand (DASH) Score,	until august 2020
Primary	Patient reported outcome score: VAS	Visual analog score (VAS)	until august 2020
Secondary	Patient demographics	male/female ratio, age, BMI, ASA (American Society of Anesthesiologists) classification, hospital stay length, range of motion	at time of surgery