LPHP-Philos-PHN Conservative Treatment

Phase 4

Completed

• Conditions: Proximal Humeral Fracture

• Registration Number: NCT00205959
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief Summary

The aim of the study is to compare the results regarding fracture healing

and functional outcome after the treatment of proximal humeral fractures

with the four different treatment methods after 12w./6months and 12 months

based on radiological evaluation as well as the "constant score" and the

"neer score".

Detailed Description

Evaluation of proximal humeral fractures using a new stable-angled implant.

Study Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

• fractures of proximal humerus
• age over 18 years
• completed skeletal development
• fracture less than 5 days old

Exclusion Criteria

• open fractures
• pseudoarthrosis, pathological or refractures
• ipsilateral fractures of distal humerus or elbow
• polytraumatic conditions
• pregnancy
• subject with known history of diseases that influence the healing process
• alcohol, drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Functional outcome based on "constant and neer score" after 12 months
Radiological comparison of the fracture healing

Secondary Outcome Measures

Name	Time	Method
Radiological evaluation of possible misallocation
Analysis of occured complications
Subjective patient judgement of before and after treatment according to DASH-questionnaire

Trial Locations

Locations (1)

Universitaestklinik Freiburg, Klinik für Traumatologie; 🇩🇪 Freiburg, Germany