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

NCT04807322 | Completed

• 1 other identifier: RTSA in very old patients
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reverse Total Shoulder Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Patient reported outcome score: ASES

  American Shoulder and Elbow Society (ASES) Score

  until august 2020

• Complication rate

  postoperative complications requiring surgical intervention

  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.

  until august 2020

• Mortality

  Survivership

  until august 2020

• Patient reported outcome score: QuickDASH

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

  until august 2020

• Patient reported outcome score: VAS

  Visual analog score (VAS)

  until august 2020

Secondary Outcomes (1)

• Patient demographics

  at time of surgery

Study Arms (2)

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

Reverse Total Shoulder Arthroplasty (RTSA) PROCEDURE

Implantation of a Reverse Total Shoulder Arthroplasty

Elective cases; Fracture cases

Eligibility Criteria

• Age: 83 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients younger than 83 years at time of surgery

Sponsors & Collaborators

• Bürgerspital Solothurn: lead

Study Sites (1)

Bürgerspital Solothurn

Solothurn, 4500, Switzerland

Location

Study Officials

• Mai Lan Dao Trong, MD

  Bürgerspital Solothurn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician shoulder and elbow surgery

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: March 24, 2019
• Primary Completion: August 4, 2020
• Study Completion: December 21, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)