Non Randomized Humerusshaft Fracture
Primary Purpose
Humerusshaft Fractures
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Humerus Nail or LC Plate
Sponsored by
About this trial
This is an interventional treatment trial for Humerusshaft Fractures focused on measuring Fractures, Humerus, Conservative treatment, Operative treatment
Eligibility Criteria
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
Sites / Locations
- Spital Uster
Outcomes
Primary Outcome Measures
- Radiological comparison of fracture healing between the conservative versus operative treatment
Radiological comparison of fracture healing between the conservative versus operative treatment
- Comparison of functional outcome
Comparison of functional outcome
Secondary Outcome Measures
- Collection of possible complication of the treatment
Collection of possible complication of the treatment
- Subject satisfaction
Subject satisfaction
- Financial impact of the compared treatments
Financial impact of the compared treatments
Full Information
NCT ID
NCT00205972
First Posted
September 13, 2005
Last Updated
August 11, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOAA Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT00205972
Brief Title
Non Randomized Humerusshaft Fracture
Official Title
Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOAA Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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".
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humerusshaft Fractures
Keywords
Fractures, Humerus, Conservative treatment, Operative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Humerus Nail or LC Plate
Primary Outcome Measure Information:
Title
- Radiological comparison of fracture healing between the conservative versus operative treatment
Description
Radiological comparison of fracture healing between the conservative versus operative treatment
Time Frame
3 months to 12 months post OP
Title
- Comparison of functional outcome
Description
Comparison of functional outcome
Time Frame
3 months to 12 months post OP
Secondary Outcome Measure Information:
Title
- Collection of possible complication of the treatment
Description
Collection of possible complication of the treatment
Time Frame
3 months to 12 months post OP
Title
- Subject satisfaction
Description
Subject satisfaction
Time Frame
3 months to 12 months post OP
Title
- Financial impact of the compared treatments
Description
Financial impact of the compared treatments
Time Frame
3 months to 12 months post OP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gian Melcher, PD MD
Organizational Affiliation
Spital Uster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spital Uster
City
Uster
ZIP/Postal Code
8610
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Non Randomized Humerusshaft Fracture
We'll reach out to this number within 24 hrs