Non Randomized Humerusshaft Fracture

August 11, 2020 updated by: AO Clinical Investigation and Publishing Documentation

Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures

The aim of the study is to radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

Study Overview

Status

Completed

Conditions

Humerusshaft Fractures

Intervention / Treatment

Device: Humerus Nail or LC Plate

Detailed Description

Radiologically compare the fracture healing as well

as the functional treatment outcome of conservative and operative treatment of

defined humerusshaft fractures after 6w./12w./and 12 month based on the

modified "constant score".

Study Type

Interventional

Enrollment

300

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Uster, Switzerland, 8610
    - Spital Uster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

over age 16
fracture according to AO classifications 12A2, 12A3, 12B2
have to be available for the FU's

Exclusion Criteria:

open fractures
polytraumatized patients
multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
pseudoarthrosis
pathological and refractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Radiological comparison of fracture healing between the conservative versus operative treatment Time Frame: 3 months to 12 months post OP	Radiological comparison of fracture healing between the conservative versus operative treatment	3 months to 12 months post OP
- Comparison of functional outcome Time Frame: 3 months to 12 months post OP	Comparison of functional outcome	3 months to 12 months post OP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Collection of possible complication of the treatment Time Frame: 3 months to 12 months post OP	Collection of possible complication of the treatment	3 months to 12 months post OP
- Subject satisfaction Time Frame: 3 months to 12 months post OP	Subject satisfaction	3 months to 12 months post OP
- Financial impact of the compared treatments Time Frame: 3 months to 12 months post OP	Financial impact of the compared treatments	3 months to 12 months post OP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

AOAA Switzerland

Investigators

Principal Investigator: Gian Melcher, PD MD, Spital Uster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria