Proximal Humeral FracturePhase 4NCT00205959
LPHP-Philos-PHN Conservative Treatment
A Phase 4 study testing Locking proximal humerus plate, Proximal Humerus Internal Locking System and Proximal Humerus Nail in people with Proximal Humeral Fracture, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Locking proximal humerus plate, Proximal Humerus Internal Locking System and Proximal Humerus Nail
- Type of treatment
- Medical device
- How many people
- 640 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2002to Aug 2006
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- fractures of proximal humerus
- age over 18 years
- completed skeletal development
- fracture less than 5 days old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitaestklinik Freiburg, Klinik für Traumatologie
Freiburg im Breisgau, 79106
About this study
Official title: Comparison of Standard Treatment Methods for Proximal Humerus Fractures
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".
Read the detailed description
Evaluation of proximal humeral fractures using a new stable-angled implant.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Locking proximal humerus plate, Proximal Humerus Internal Locking System, Proximal Humerus Nail
- Keywords
- Humerus, Fractures, Locking Plates, Nail System
- Medical subject headings
- Shoulder Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking proximal humerus plateDevice
Proximal Humerus Internal Locking SystemDevice
Proximal Humerus NailDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological comparison of the fracture healing
Functional outcome based on "constant and neer score" after 12 months
Secondary outcomes (3)
Analysis of occured complications
Radiological evaluation of possible misallocation
Subjective patient judgement of before and after treatment according to DASH-questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2002
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 640 participants
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Synthes Inc., AO Research Fund
- Investigators
- Norbert Südkamp, Prof. MD, Principal investigator, Universitaetsklinik Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205959
- Sponsor's protocol ID
- 02-LPP-04
- Status last verified
- Aug 2020
- First submitted
- 13 Sep 2005
- Last updated
- 14 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Treatment Methods for Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT00205959
- Acronym / sponsor ID
- 02-LPP-04
- Conditions
- Proximal Humeral Fracture
- Keywords
- Humerus, Fractures, Locking Plates, Nail System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Synthes Inc., AO Research Fund
- Study start
- Aug 2002
- Study completion
- Aug 2006
- First posted
- 21 Sep 2005 (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 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".
Detailed description
Evaluation of proximal humeral fractures using a new stable-angled implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- fractures of proximal humerus
- age over 18 years
- completed skeletal development
- fracture less than 5 days old
Key exclusion criteria (7 listed)
- open fractures
- pseudoarthrosis, pathological or refractures
- ipsilateral fractures of distal humerus or elbow
- polytraumatic conditions
- pregnancy
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 |
|---|---|---|
| Locking proximal humerus plate | Device | – |
| Proximal Humerus Internal Locking System | Device | – |
| Proximal Humerus Nail | Device | – |
Primary outcome
Radiological comparison of the fracture healing
Functional outcome based on "constant and neer score" after 12 months
3 secondary outcomes
Analysis of occured complications
Radiological evaluation of possible misallocation
Subjective patient judgement of before and after treatment according to DASH-questionnaire
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 14 Aug 2020.
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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.
Norbert Südkamp, Prof. MD principal investigator
Universitaetsklinik Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Locking proximal humerus plate, Proximal Humerus Internal Locking System and Proximal Humerus Nail in people with Proximal Humeral Fracture, run by AO Clinical Investigation and Publishing Documentation at 1 site in Germany.
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 7 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 14 Aug 2020. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Radiological comparison of the fracture healing. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2020; AzTrials last refreshed its copy on 28 Oct 2026.