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Completed

NCT Number: NCT02566018

Treatment of Proximal Humerus Fractures in the Elderly

This study is set to evaluate a proposed standard for the treatment of proximal humerus fractures

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Key information

Conditions

Humeral Fractures Arm Injuries Fractures, Bone Wounds and Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, 4021, Switzerland

About this study

This study investigates the effect of routine treatment algorithm for proximal humerus fractures. All applied treatments are approved and reflect routine practice. The follow-up investigation as planned for this study is associated with only minimal risk for the concerned patients.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age of 65 years or above
  • Proximal humerus fracture
  • Informed consent by the patient or legal representatives to participate in the study

Exclusion criteria

  • More than one fracture, polytrauma
  • Suspicion of a pathological fracture in the context of known or unknown malignancy
  • Previous surgery of the proximal humerus on the same side
  • High energy trauma
  • Open Fracture
  • Insufficient German language skills

Treatment and study plan

treatment/medical device

Procedure

The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards

standard

Procedure

The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.

Primary outcomes

  1. personal dependency status

    Time frame: 6 months

    A simple four point rating is used at the time of injury (for the premorbid state) and at 6 months to demonstrate the impact of the injury (including its treatment) on the ability to return to the former social environment and degree of self-dependency.

Secondary outcomes

  1. range of motion

    Time frame: 6 months

  2. Shoulder pain and disability index (SPADI)

    Time frame: 6 months

    The SPADI is a patient-based questionnaire containing 15 questions about pain and activities of daily living that must be answered by the patient on a scale of 0-10 (0 = no pain / no difficulties to 10 = Worst pain / activity). Five questions relate to the pain and 8 questions relate to the function in daily activities, both subscores are combined and converted to the total score to 0 (= lowest score) to 100 (= best result). A validated German version is available

  3. SSV

    Time frame: 6 months

    The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The English formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" 12 It is an easily administered measure of shoulder function.

  4. General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)

    Time frame: 6 months

    The gain in quality of life within two years after surgery is assessed using the generic Quality of Life (QoL) EuroQoL EQ-5D-5L instrument.

  5. Quality of life (utilities) derived using EQ-5D-5L

    Time frame: 6 months

    Using the EQ-5D-5L instrument patients are asked to report on their general health status on a VAS scale from 0 (worst possible health) to 100 (best possible health).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Treatment Options for Proximal Humerus Fractures in the Elderly and Their Implication on Personal Independence

Acronym: prox_hum

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2015
Registry last updated
May 14, 2024

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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