Humerusshaft FracturesPhase 4NCT00205972
Non Randomized Humerusshaft Fracture
A Phase 4 study testing Humerus Nail or LC Plate in people with Humerusshaft Fractures, run by AO Clinical Investigation and Publishing Documentation at 1 site in Switzerland.
Trial summary
The aim of the study is to radiologically compare the fracture healing as well as the functional treatment outcome of conservative and operative treatment of defined humerusshaft fractures after 6w./12w./and 12 month based on the modified "constant score". Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Humerusshaft Fractures
- What is being tested?
- Humerus Nail or LC Plate
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2000to Oct 2004
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- over age 16
- fracture according to AO classifications 12A2, 12A3, 12B2
- have to be available for the FU's
Who cannot join
- open fractures
- polytraumatized patients
- multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
- pseudoarthrosis
- pathological and refractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures
The aim of the study is to radiologically compare the fracture healing as well
as the functional treatment outcome of conservative and operative treatment of
defined humerusshaft fractures after 6w./12w./and 12 month based on the
modified "constant score".
Read the detailed description
Radiologically compare the fracture healing as well
as the functional treatment outcome of conservative and operative treatment of
defined humerusshaft fractures after 6w./12w./and 12 month based on the
modified "constant score".
- Conditions
- Humerusshaft Fractures
- Being tested
- Humerus Nail or LC Plate
- Keywords
- Fractures, Humerus, Conservative treatment, Operative treatment
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humerus Nail or LC PlateDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
- Radiological comparison of fracture healing between the conservative versus operative treatment
Radiological comparison of fracture healing between the conservative versus operative treatment
Measured: 3 months to 12 months post OP
- Comparison of functional outcome
Comparison of functional outcome
Measured: 3 months to 12 months post OP
Secondary outcomes (3)
- Collection of possible complication of the treatment
Collection of possible complication of the treatment
Measured: 3 months to 12 months post OP
- Subject satisfaction
Subject satisfaction
Measured: 3 months to 12 months post OP
- Financial impact of the compared treatments
Financial impact of the compared treatments
Measured: 3 months to 12 months post OP
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 startDec 2000
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerusshaft FracturesStudies 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- AOAA Switzerland
- Responsible party
- Sponsor
- Investigators
- Gian Melcher, PD MD, Principal investigator, Spital Uster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205972
- Sponsor's protocol ID
- 00-NRH-04
- Status last verified
- Aug 2020
- First submitted
- 13 Sep 2005
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures
- ClinicalTrials.gov ID
- NCT00205972
- Acronym / sponsor ID
- 00-NRH-04
- Conditions
- Humerusshaft Fractures
- Keywords
- Fractures, Humerus, Conservative treatment, Operative treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- AOAA Switzerland
- Study start
- Dec 2000
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- 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 radiologically compare the fracture healing as well
as the functional treatment outcome of conservative and operative treatment of
defined humerusshaft fractures after 6w./12w./and 12 month based on the
modified "constant score".
Detailed description
Radiologically compare the fracture healing as well
as the functional treatment outcome of conservative and operative treatment of
defined humerusshaft fractures after 6w./12w./and 12 month based on the
modified "constant score".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- over age 16
- fracture according to AO classifications 12A2, 12A3, 12B2
- have to be available for the FU's
Key exclusion criteria (5 listed)
- open fractures
- polytraumatized patients
- multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing
- pseudoarthrosis
- pathological and refractures
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 |
|---|---|---|
| Humerus Nail or LC Plate | Device | – |
Primary outcome
- Radiological comparison of fracture healing between the conservative versus operative treatment
Time frame: 3 months to 12 months post OP
Radiological comparison of fracture healing between the conservative versus operative treatment
- Comparison of functional outcome
Time frame: 3 months to 12 months post OP
Comparison of functional outcome
3 secondary outcomes
- Collection of possible complication of the treatment
Time frame: 3 months to 12 months post OP
- Subject satisfaction
Time frame: 3 months to 12 months post OP
- Financial impact of the compared treatments
Time frame: 3 months to 12 months post OP
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 13 Aug 2020.
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.
Gian Melcher, PD MD principal investigator
Spital Uster
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 Humerus Nail or LC Plate in people with Humerusshaft Fractures, run by AO Clinical Investigation and Publishing Documentation at 1 site in Switzerland.
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 3 inclusion and 5 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 13 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 Switzerland. 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 fracture healing between the conservative versus operative treatment (time frame: 3 months to 12 months post OP). 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 13 Aug 2020.