ComplicationClavFracNCT02247778
Surgical Innovations in Treatment of Clavicle Fractures
A study testing conventional plate osteosynthesis and mini-incision-type osteosynthesis in people with Complication, run by Technical University of Munich at 1 site in Germany.
Trial summary
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complication
- What is being tested?
- conventional plate osteosynthesis and mini-incision-type osteosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Sep 2015
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent
Who cannot join
- all other patients
Trial locations and contacts
1 site in 1 country.
Chlodwig Kirchhoff, MD contact
Marc Beirer, MD contact
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, 81675
Peter Biberthaler, MD, 0049-(0)89-41402126, peter.biberthaler@mri.tum.de
Chlodwig Kirchhoff, MD
About this study
Official title: Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.
The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.
Read the detailed description
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.
The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a prospective observational protocol was chosen.
- Conditions
- Complication
- Being tested
- conventional plate osteosynthesis, mini-incision-type osteosynthesis
- Keywords
- clavicle, surgical intervention, mini-incision, plate osteosynthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional plate osteosynthesisProcedure or surgery
Standard incision
mini-incision-type osteosynthesisProcedure or surgery
Mini-incision
| Study group | Role | What they receive |
|---|---|---|
| conventional plate osteosynthesis | Active comparator | Standard procedure Receives: Procedure: conventional plate osteosynthesis |
| mini-incision-type osteosynthesis | Active comparator | mini-incision Receives: Procedure: mini-incision-type osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
area of paresthetic skin
Measured: 12 month
Secondary outcomes (2)
Time to fracture healing
Measured: 12 month
Postoperative shoulder function
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2015 (estimated)
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 ComplicationStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chlodwig Kirchhoff, Technical University of Munich
- Investigators
- Chlodwig Kirchhoff, MD, Principal investigator, Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247778
- Sponsor's protocol ID
- Beiromat_02
- Acronym
- ClavFrac
- Status last verified
- Sep 2014
- First submitted
- 21 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Beirer M, Postl L, Cronlein M, Siebenlist S, Huber-Wagner S, Braun KF, Biberthaler P, Kirchhoff C. Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures? BMC Musculoskelet Disord. 2015 May 28;16:128. doi: 10.1186/s12891-015-0592-4.
PubMed 26018526
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle
- ClinicalTrials.gov ID
- NCT02247778
- Acronym / sponsor ID
- ClavFrac / Beiromat_02
- Conditions
- Complication
- Keywords
- clavicle, surgical intervention, mini-incision, plate osteosynthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Sep 2014 (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.
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.
The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.
Detailed description
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm.
The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access. Therefore a prospective observational protocol was chosen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional plate osteosynthesis | Active comparator | Procedure: conventional plate osteosynthesisStandard procedure |
| mini-incision-type osteosynthesis | Active comparator | Procedure: mini-incision-type osteosynthesismini-incision |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent
Key exclusion criteria (1 listed)
- all other patients
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 |
|---|---|---|
| conventional plate osteosynthesisStandard incision | Procedure or surgery | conventional plate osteosynthesis |
| mini-incision-type osteosynthesisMini-incision | Procedure or surgery | mini-incision-type osteosynthesis |
Primary outcome
area of paresthetic skin
Time frame: 12 month
2 secondary outcomes
Time to fracture healing
Time frame: 12 month
Postoperative shoulder function
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Derived from this study: PubMed 26018526Beirer M, Postl L, Cronlein M, Siebenlist S, Huber-Wagner S, Braun KF, Biberthaler P, Kirchhoff C. Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures? BMC Musculoskelet Disord. 2015 May 28;16:128. doi: 10.1186/s12891-015-0592-4.
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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.
Chlodwig Kirchhoff, MD contact
Marc Beirer, MD contact
Chlodwig Kirchhoff, MD principal investigator
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional plate osteosynthesis and mini-incision-type osteosynthesis in people with Complication, run by Technical University of Munich 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chlodwig Kirchhoff, MD (chlodwig.kirchhoff@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area of paresthetic skin (time frame: 12 month). 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 NCT02247778, 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 30 Sep 2014.