Treatment of Proximal Humerus Fractures in the Elderly (prox_hum)

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

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

Study Overview

• Status: Completed
• Conditions: Humeral Fractures
• Intervention / Treatment: Procedure: treatment/medical device; Procedure: standard

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4021
      • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients fulfilling all of the following inclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experimental intervention; A greater degree of initial displacement is tolerated to allow for conservative, non-operative treatment in more simple fracture patterns. Two-part fractures with marked displacement including two part patterns with a non-displaced greater or minor tuberosity fracture (formally three part fractures) are treated with a proximal humerus nail; and displaced three and four part fractures are primarily managed with a reverse total shoulder arthroplasty. Proximal Humeral Internal Locking System (PHILOS)-plates are only used exceptionally in this group of patients.	Procedure: treatment/medical device; The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards
control intervention; Since May 2013 we have changed our treatment algorithm for the treatment of fractures of the humeral head in the elderly. Before this change in algorithm we used PHILOS plates extensively and rarely Inverse Shoulder prostheses. In general all proximal humerus fractures were operated except minimally or undisplaced.	Procedure: standard; The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
personal dependency status	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion		6 months
Shoulder pain and disability index (SPADI)	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	6 months
SSV	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.	6 months
General health using EuroQuality of life (EQ)-5D-5L visual analogue scale (VAS)	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.	6 months
Quality of life (utilities) derived using EQ-5D-5L	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).	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Daniel Rikli, Prof, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Schurch MA, Rizzoli R, Mermillod B, Vasey H, Michel JP, Bonjour JP. A prospective study on socioeconomic aspects of fracture of the proximal femur. J Bone Miner Res. 1996 Dec;11(12):1935-42. doi: 10.1002/jbmr.5650111215.
• Rikli D, Feissli S, Muller AM, Steinitz A, Suhm N, Jakob M, Audige L. High rate of maintaining self-dependence and low complication rate with a new treatment algorithm for proximal humeral fractures in the elderly population. J Shoulder Elbow Surg. 2020 Jun;29(6):1127-1135. doi: 10.1016/j.jse.2019.11.006. Epub 2020 Feb 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: elderly
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: EKNZ 2014-310