Treatment of Proximal Humerus Fractures in the Elderly

NCT ID: NCT02566018

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Humeral Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

treatment/medical device

Intervention Type PROCEDURE

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.

standard

Intervention Type PROCEDURE

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

Interventions

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treatment/medical device

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

Intervention Type PROCEDURE

standard

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Rikli, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 8970896 (View on PubMed)

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.

Reference Type RESULT
PMID: 32057657 (View on PubMed)

Other Identifiers

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2014-310

Identifier Type: -

Identifier Source: org_study_id

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