Treatment of Proximal Humerus Fractures in the Elderly

Humeral Fractures Clinical Trial

— prox_hum  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566018
• Other study ID #: EKNZ 2014-310
• Status: Completed
• Start date: May 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

Intervention

Procedure:
• treatment/medical device
The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards
• standard
The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Rikli D, Feissli S, Müller AM, Steinitz A, Suhm N, Jakob M, Audigé 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 J — View Citation

Schürch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	range of motion		6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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