FractureNCT00408291
Evaluation of Treatment of Fractures of the Humerus With a Plate.
An observational study of Fracture, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Fracture
- What is being tested?
- Winsta PH osteosynthesis device
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be included at 2 orthopaedic departments at 2 hospitals
Who may be able to join
- Patients with three-part and four-part proximal humeral fractures
- Aged 50 years or older and fit
- Informed, written consent
- A functioning shoulder preoperatively -
Who cannot join
- 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
Show all 9Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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)
- Conditions
- Fracture
- Being tested
- Winsta PH osteosynthesis device
- Keywords
- fracture, shoulder, bone density, healing
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winsta PH osteosynthesis deviceProcedure or surgery
Also called Winsta PH osteosynthesis device (Fischer Medical)
The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Winsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture Receives: Procedure: Winsta PH osteosynthesis device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
Migration of the tubercles measured with Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA)
Measured: five years
Secondary outcomes (5)
Correlation between bone density and prosthesis migration (and tuberculum migration)
Measured: five years
Range of Motion (ROM)
Measured: five years
Muscle strength
Measured: five years
Activities of Daily Living (ADL)
Measured: five years
Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startDec 2011
- Primary completionApr 2022
- Study completionMar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, Professor, Study director, Orthopaedic Department, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408291
- Sponsor's protocol ID
- 20060166
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2006
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00408291
- Acronym / sponsor ID
- 20060166
- Conditions
- Fracture
- Keywords
- fracture, shoulder, bone density, healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- Apr 2022 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 6 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Winsta PH osteosynthesis deviceWinsta PH osteosynthesis device (Fischer Medical)for treatment of humeral fracture |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be included at 2 orthopaedic departments at 2 hospitals
Key inclusion criteria (4 listed)
- Patients with three-part and four-part proximal humeral fractures
- Aged 50 years or older and fit
- Informed, written consent
- A functioning shoulder preoperatively -
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winsta PH osteosynthesis deviceAlso: Winsta PH osteosynthesis device (Fischer Medical)The Winsta PH osteosynthesis device have been developed for use in treatment of proximal humerus fractures. | Procedure or surgery | 1 |
Primary outcome
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)
5 secondary outcomes
Correlation between bone density and prosthesis migration (and tuberculum migration)
Time frame: five years
Range of Motion (ROM)
Time frame: five years
Muscle strength
Time frame: five years
Activities of Daily Living (ADL)
Time frame: five years
Bone density in the proximal humerus measured with Dual Energy X-ray Absorptiometry (DEXA)
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kjeld Soballe, Professor study director
Orthopaedic Department, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (migration) of tuberculum majus and minus measured with use of Model-Based Roentgen Stereophotogrammetric Analysis (MB-RSA) (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.