LPHP-Philos-PHN Conservative Treatment | NCT00205959

Studies
LPHP-Philos-PHN Conservative Treatment

NCT00205959

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Completed

Last Update Posted

Aug 14, 2020Actual

Enrollment

640

Phase

Phase 4

Conditions

Proximal Humeral Fracture

Interventions

Locking proximal humerus plate
Proximal Humerus Internal Locking System
Proximal Humerus Nail

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2002

Primary Completion Date

Not provided

Completion Date

Aug 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2020

Last Update Posted Date

Aug 14, 2020Actual

Name	Class
Synthes Inc.	INDUSTRY
AO Research Fund	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

640

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiological comparison of the fracture healing
Functional outcome based on "constant and neer score" after 12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Norbert Südkamp, Prof. MD	Universitaetsklinik Freiburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitaestklinik Freiburg, Klinik für Traumatologie		Freiburg im Breisgau		79106	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012784	Shoulder Fractures
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D000070599	Shoulder Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Locking proximal humerus plate	Device
Proximal Humerus Internal Locking System	Device
Proximal Humerus Nail	Device