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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
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humerusshaft Fractures focused on measuring Fractures, Humerus, Conservative treatment, Operative treatment

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
August 11, 2020
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
AOAA Switzerland
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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

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