Non Randomized Humerusshaft Fracture

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00205972

Enrollment

300

Registered

2005-09-21

Start date

2000-12-31

Completion date

2004-10-31

Last updated

2020-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humerusshaft Fractures

Keywords

Fractures, Humerus, Conservative treatment, Operative treatment

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.

Interventions

DEVICEHumerus Nail or LC Plate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026