Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408291
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2006-12-05
Brief Title:
Evaluation of Treatment of Fractures of the Humerus With a Plate
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Evaluation of the Winsta PH Osteosynthesis Device in the Treatment of Three- and Four-Part Fractures of the Proximal Humerus A Prospective Migration and Bone Density Study
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to study with the use of clinical and radiological parameters the treatment of three-part and four-part fractures with the Winsta PH osteosynthesis device Fischer Medical
Detailed Description:
We shall measure the following clinical parameters with the help of the Constant Shoulder Score CSS and Western Ontario Osteoarthritis of the Shoulder Index WOOS
1 Pain
2 Activities of Daily Living ADL
3 Range of Motion ROM
4 Muscle strength
We shall measure the following radiologic parameters
1 Healing migration of tuberculum majus and minus measured with use of MB-RSA
2 Plate migration with use of MB-RSA
3 Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry DEXA
4 Correlation between bone density and prosthesis migration and tuberculum migration
1 Pain
2 Activities of Daily Living ADL
3 Range of Motion ROM
4 Muscle strength
We shall measure the following radiologic parameters
1 Healing migration of tuberculum majus and minus measured with use of MB-RSA
2 Plate migration with use of MB-RSA
3 Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry DEXA
4 Correlation between bone density and prosthesis migration and tuberculum migration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None