NCT00205959

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

First QC Date

September 13, 2005

Last Update Submit

August 12, 2020

Conditions

Proximal Humeral Fracture

Keywords

HumerusFracturesLocking PlatesNail System

Outcome Measures

Primary Outcomes (2)

  • Radiological comparison of the fracture healing

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

Secondary Outcomes (3)

  • Analysis of occured complications

  • Radiological evaluation of possible misallocation

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

Interventions

Locking proximal humerus plateDEVICE
Proximal Humerus Internal Locking SystemDEVICE
Proximal Humerus NailDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitaestklinik Freiburg, Klinik für Traumatologie

Freiburg im Breisgau, 79106, Germany

Location

MeSH Terms

Conditions

Shoulder FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesShoulder Injuries

Study Officials

  • Norbert Südkamp, Prof. MD

    Universitaetsklinik Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2002

Study Completion

August 1, 2006

Last Updated

August 14, 2020

Record last verified: 2020-08

Locations

DE(1)