NCT03272490

Brief Summary

20 patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current study since 2014. After completing the randomization plan, patients were distributed into two groups for different variable angle locking plates (DePuy Synthes VA-LCP vs. Medartis Aptus Elbow). Clinical and radiological follow-ups were conducted 6 weeks, 12 weeks, 6 months and 12 months after the operation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

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

February 5, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2017

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
Last Updated

September 5, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

August 31, 2017

Last Update Submit

September 1, 2017

Conditions

Distal Humerus Fracture

Keywords

locking plateanatomical preshapedpolyaxialoutcome

Outcome Measures

Primary Outcomes (1)

  • Mayo Elbow Performance Score (MEPS)

    clinical and functional outcome

    12 months

Study Arms (2)

Medartis

ACTIVE COMPARATOR

Surgery using the Medartis Implant

Procedure: Medartis

Synthes

ACTIVE COMPARATOR

Surgery using the Synthes implant

Procedure: Synthes

Interventions

MedartisPROCEDURE

Surgery using the medartis implant

Medartis
SynthesPROCEDURE

Surgery using the Synthes implant

Synthes

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cronlein M, Lucke M, Beirer M, Pforringer D, Kirchhoff C, Biberthaler P, Braun KF, Siebenlist S. Polyaxial locking plates in treating distal humeral fractures: a comparative randomized trial for clinical outcome. BMC Musculoskelet Disord. 2017 Dec 28;18(1):547. doi: 10.1186/s12891-017-1910-9.

    PMID: 29282027DERIVED

MeSH Terms

Conditions

Humeral Fractures, Distal

Condition Hierarchy (Ancestors)

Elbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesHumeral FracturesFractures, Bone

Study Officials

  • Peter Bibethaler, Prof.

    Department of Trauma Surgery Klinikum rechts der Isar Technical University of Munich, Germany Ismaninger Strasse 22 81675 Munich, Germany

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

February 5, 2014

Primary Completion

June 6, 2017

Study Completion

July 1, 2017

Last Updated

September 5, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share