Evaluation of Treatment of Fractures of the Humerus With a Plate.
January 12, 2024 updated by: University of Aarhus
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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):
- Pain
- Activities of Daily Living (ADL)
- Range of Motion (ROM)
- Muscle strength
We shall measure the following radiologic parameters:
- Healing (migration) of tuberculum majus and minus measured with use of MB-RSA
- Plate migration with use of MB-RSA
- Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
- Correlation between bone density and prosthesis migration (and tuberculum migration)
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Silkeborg, Denmark, 8600
- Orthopaedic Department K, Silkeborg Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study population will be included at 2 orthopaedic departments at 2 hospitals
Description
Inclusion Criteria:
- Patients with three-part and four-part proximal humeral fractures
- Aged 50 years or older and fit
- Informed, written consent
- A functioning shoulder preoperatively -
Exclusion Criteria:
- Patients found unsuitable preoperatively for a shoulder Philos Plate
- Patients aged 85 or older
- Patients with rheumatoid arthritis
- Patients who previously had undergone shoulder plastic or other major shoulder surgery
- Patients unable to avoid NSAID after surgery
- Patients requiring regular systemic steroid treatment
- Female patients taking hormone substitution
- Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings)
- Patients with metabolic bone disease -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture
|
The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
Time Frame: five years
|
Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
|
five years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation between bone density and prosthesis migration (and tuberculum migration)
Time Frame: five years
|
five years
|
|
Range of Motion (ROM)
Time Frame: five years
|
five years
|
|
Muscle strength
Time Frame: five years
|
five years
|
|
Activities of Daily Living (ADL)
Time Frame: five years
|
five years
|
|
Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
Time Frame: five years
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kjeld Soballe, Professor, Orthopaedic Department, Aarhus University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2011
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
December 5, 2006
First Submitted That Met QC Criteria
December 5, 2006
First Posted (Estimated)
December 6, 2006
Study Record Updates
Last Update Posted (Estimated)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 12, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20060166
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.