Non Randomized Humerusshaft Fracture

Humerusshaft Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205972
• Other study ID #: 00-NRH-04
• Status: Completed
• Phase: Phase 4
• Start date: December 2000
• Est. completion date: October 2004

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humerusshaft Fractures

Intervention

Device:
• Humerus Nail or LC Plate

Locations

Country	Name	City	State
Switzerland	Spital Uster	Uster

Sponsors (2)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation	AOAA Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Radiological comparison of fracture healing between the conservative versus operative treatment	Radiological comparison of fracture healing between the conservative versus operative treatment	3 months to 12 months post OP
Primary	- Comparison of functional outcome	Comparison of functional outcome	3 months to 12 months post OP
Secondary	- Collection of possible complication of the treatment	Collection of possible complication of the treatment	3 months to 12 months post OP
Secondary	- Subject satisfaction	Subject satisfaction	3 months to 12 months post OP
Secondary	- Financial impact of the compared treatments	Financial impact of the compared treatments	3 months to 12 months post OP