NCT02566018

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

4.7 years

First QC Date

September 30, 2015

Last Update Submit

May 13, 2024

Conditions

Humeral Fractures

Keywords

elderly

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • range of motion

    6 months

  • Shoulder pain and disability index (SPADI)

    6 months

  • SSV

    6 months

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

    6 months

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

    6 months

Study Arms (2)

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

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

Interventions

treatment/medical devicePROCEDURE

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

experimental intervention
standardPROCEDURE

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

control intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients fulfilling all of the following inclusion criteria

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4021, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 8970896RESULT

  • 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.

    PMID: 32057657RESULT

MeSH Terms

Conditions

Humeral Fractures

Interventions

TherapeuticsEquipment and Supplies

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Daniel Rikli, Prof

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

May 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

CH(1)