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OpenTrials
Completed

NCT Number: NCT00205972

Non Randomized Humerusshaft Fracture

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".

Completed

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Key information

Conditions

Humerusshaft Fractures Fractures, Bone Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Spital Uster

Uster, 8610, Switzerland

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Humerus Nail or LC Plate

Device

Primary outcomes

  1. - 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

  2. - Comparison of functional outcome

    Time frame: 3 months to 12 months post OP

    Comparison of functional outcome

Secondary outcomes

  1. - Collection of possible complication of the treatment

    Time frame: 3 months to 12 months post OP

    Collection of possible complication of the treatment

  2. - Subject satisfaction

    Time frame: 3 months to 12 months post OP

    Subject satisfaction

  3. - Financial impact of the compared treatments

    Time frame: 3 months to 12 months post OP

    Financial impact of the compared treatments

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Collaborators

  • AOAA Switzerland

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Sep 21, 2005
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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