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NCT00205959 Clinical Trial

LPHP-Philos-PHN Conservative Treatment

Proximal Humeral Fracture Clinical Trial

Official title:
Comparison of Standard Treatment Methods for Proximal Humerus Fractures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00205959
Other study ID # 02-LPP-04
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2002
Est. completion date August 2006

Study information
Verified date August 2020
Source AO Innovation Translation Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 640
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Locking proximal humerus plate

• Proximal Humerus Internal Locking System

• Proximal Humerus Nail

Locations
Country Name City State
Germany Universitaestklinik Freiburg, Klinik für Traumatologie Freiburg

Sponsors (3)
Lead Sponsor Collaborator
AO Clinical Investigation and Publishing Documentation AO Research Fund, Synthes Inc.

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiological comparison of the fracture healing
Primary Functional outcome based on "constant and neer score" after 12 months
Secondary Analysis of occured complications
Secondary Radiological evaluation of possible misallocation
Secondary Subjective patient judgement of before and after treatment according to DASH-questionnaire
See also
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Recruiting NCT04762667 - Individual Preoperative Planning for RSA N/A
Active, not recruiting NCT03531463 - The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly N/A
Terminated NCT03711591 - Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
Completed NCT03339570 - Orthopaedic Treatment Proximal Humeral Fractures
Completed NCT03919422 - Paravertebral Block for Proximal Humeral Fracture Surgery N/A
Completed NCT01984112 - Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts N/A
Completed NCT00863473 - Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment Phase 2
Not yet recruiting NCT06416618 - Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years N/A
Recruiting NCT04543682 - A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture Phase 1/Phase 2
Completed NCT05215613 - PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
Recruiting NCT04748016 - 3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair N/A
Completed NCT04786639 - Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
Active, not recruiting NCT04623346 - Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
Recruiting NCT05437822 - Tranexamic Acid in Proximal Humeral Fractures Phase 4
Terminated NCT03567954 - The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients
Recruiting NCT03626038 - Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System N/A
Not yet recruiting NCT05960435 - Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures N/A
Recruiting NCT03243409 - Perioperative Complications in Reversed Shoulder Arthroplasties N/A