NCT00408291

Evaluation of Treatment of Fractures of the Humerus With a Plate.

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
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Fracture

Interventions

Type	Name	Description
PROCEDURE	Winsta PH osteosynthesis device	The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.

Timeline

• Start date: 2011-12-01
• Primary completion: 2022-04-01
• Completion: 2023-03-01
• First posted: 2006-12-06
• Last updated: 2024-01-17

Locations

1 site across 1 country: Denmark