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Completed

NCT Number: NCT04807322

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

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.

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Key information

Conditions

Reverse Total Shoulder Arthroplasty

Age range

83 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bürgerspital Solothurn

Solothurn, 4500, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reverse Total Shoulder Arthroplasty (RTSA)

Procedure

Implantation of a Reverse Total Shoulder Arthroplasty

Primary outcomes

  1. Patient reported outcome score: ASES

    Time frame: until august 2020

    American Shoulder and Elbow Society (ASES) Score

  2. Complication rate

    Time frame: until august 2020

    postoperative complications requiring surgical intervention

  3. 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.

  4. Mortality

    Time frame: until august 2020

    Survivership

  5. Patient reported outcome score: QuickDASH

    Time frame: until august 2020

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

  6. Patient reported outcome score: VAS

    Time frame: until august 2020

    Visual analog score (VAS)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bürgerspital Solothurn

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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