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Polyaxial Locking Plates in Treating Distal Humeral Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03272490
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Chlodwig Kirchhoff, Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Distal Humerus Fracture Procedure: Medartis Procedure: Synthes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Polyaxial Locking Plates in Treating Distal Humeral Fractures: a Comparative Randomized Trial for Clinical Outcome
Actual Study Start Date : February 5, 2014
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : July 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Medartis
Surgery using the Medartis Implant
Procedure: Medartis
Surgery using the medartis implant

Active Comparator: Synthes
Surgery using the Synthes implant
Procedure: Synthes
Surgery using the Synthes implant




Primary Outcome Measures :
  1. Mayo Elbow Performance Score (MEPS) [ Time Frame: 12 months ]
    clinical and functional outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment

Exclusion Criteria:

  • The exclusion criteria involve all under-aged patients (< 18 years), pregnant patients and patients with a mental disorder as well as patients under comprehensive legal support. In addition, pathological fractures had been excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272490


Sponsors and Collaborators
Technische Universität München
Investigators
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Study Director: Peter Bibethaler, Prof. Department of Trauma Surgery Klinikum rechts der Isar Technical University of Munich, Germany Ismaninger Strasse 22 81675 Munich, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chlodwig Kirchhoff, Principal Investigator, Technische Universität München
ClinicalTrials.gov Identifier: NCT03272490    
Other Study ID Numbers: 12345
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Chlodwig Kirchhoff, Technische Universität München:
locking plate
anatomical preshaped
polyaxial
outcome
Additional relevant MeSH terms:
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Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries