CClinicalTrials.gg
CompletedNCT00205959Updated Aug 14, 2020

LPHP-Philos-PHN Conservative Treatment

A Phase 4 interventional study of Locking proximal humerus plate and Proximal Humerus Internal Locking System in Proximal Humeral Fracture, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-14.

Sponsored by AO Clinical Investigation and Publishing Documentation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
640
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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".

Read the detailed description

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

02

Conditions studied

  • Proximal Humeral Fracture

Keywords

  • Humerus
  • Fractures
  • Locking Plates
  • Nail System
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 640 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

AO Clinical Investigation and Publishing Documentation is the lead sponsor of 49 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
640 participants

Interventions

  • DeviceLocking proximal humerus plate
  • DeviceProximal Humerus Internal Locking System
  • DeviceProximal Humerus Nail
06

What researchers measure

Primary outcomes

  1. Radiological comparison of the fracture healing

  2. Functional outcome based on "constant and neer score" after 12 months

Secondary outcomes

  1. Analysis of occured complications

  2. Radiological evaluation of possible misallocation

  3. Subjective patient judgement of before and after treatment according to DASH-questionnaire

07

Study locations

1 site
  • Universitaestklinik Freiburg, Klinik für Traumatologie
    Freiburg, 79106, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00205959
Lead sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc., AO Research Fund
First posted
Sep 21, 2005
Start date
Aug 2002
Completion
Aug 2006
Last update
Aug 14, 2020

Study contacts

Norbert Südkamp, Prof. MD
principal investigator · Universitaetsklinik Freiburg
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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