Fracture, Closed, Comminuted, HealingLatClavNCT02256059
Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension
An observational study of Fracture, Closed, Comminuted, Healing, run by Technical University of Munich at 1 site in Germany.
Trial summary
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fracture, Closed, Comminuted, Healing
- What is being tested?
- Plate osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Sep 2014
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.
Who may be able to join
- Dislocated fracture of the lateral clavicle
- Informed consent.
Who cannot join
- Patients with a history of any other pathology such as preexisting rotator cuff tear, gleno-humeral instability, glenohumeral osteoarthritis (> Samilson I), Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying tendonitis, biceps pathology or signs of cervical root symptoms
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.
Read the detailed description
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.
In this prospective study patients with dislocated fractures of the lateral clavicle (Jäger\&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability is evaluated using the Taft-Score.
- Conditions
- Fracture, Closed, Comminuted, Healing
- Being tested
- Plate osteosynthesis
- Medical subject headings
- Fractures, Bone, Fractures, Comminuted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate osteosynthesisProcedure or surgery
Plate osteosynthesis using LCP plate (Synthes)
| Study group | Role | What they receive |
|---|---|---|
| Plate osteosynthesis | Patients with fracture of the lateral clavicle and indication for surgical treatment Receives: Procedure: Plate osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone healing
time until bone healing, visualized using conventional x-ray in two planes
Measured: 12 month
Secondary outcomes (1)
shoulder function
shoulder function assessed using Munich Shoulder Questionnaire [MSQ]
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 posted3 Oct 2014 (estimated)
- Study startJun 2011
- Primary completionSep 2013
- Study completionSep 2014
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 Fracture, Closed, Comminuted, HealingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
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
- NCT02256059
- Sponsor's protocol ID
- Beiromat_03
- Acronym
- LatClav
- Status last verified
- Sep 2014
- First submitted
- 28 Sep 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Beirer M, Siebenlist S, Cronlein M, Postl L, Huber-Wagner S, Biberthaler P, Kirchhoff C. Clinical and radiological outcome following treatment of displaced lateral clavicle fractures using a locking compression plate with lateral extension: a prospective study. BMC Musculoskelet Disord. 2014 Nov 19;15:380. doi: 10.1186/1471-2474-15-380.
PubMed 25406639
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study
- ClinicalTrials.gov ID
- NCT02256059
- Acronym / sponsor ID
- LatClav / Beiromat_03
- Conditions
- Fracture, Closed, Comminuted, Healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Oct 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.
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.
Detailed description
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.
In this prospective study patients with dislocated fractures of the lateral clavicle (Jäger\&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability is evaluated using the Taft-Score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plate osteosynthesis | – | Procedure: Plate osteosynthesisPatients with fracture of the lateral clavicle and indication for surgical treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.
Key inclusion criteria (2 listed)
- Dislocated fracture of the lateral clavicle
- Informed consent.
Key exclusion criteria (1 listed)
- Patients with a history of any other pathology such as preexisting rotator cuff tear, gleno-humeral instability, glenohumeral osteoarthritis (> Samilson I), Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying tendonitis, biceps pathology or signs of cervical root symptoms
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 |
|---|---|---|
| Plate osteosynthesisPlate osteosynthesis using LCP plate (Synthes) | Procedure or surgery | Plate osteosynthesis |
Primary outcome
bone healing
Time frame: 12 month
time until bone healing, visualized using conventional x-ray in two planes
1 secondary outcome
shoulder function
Time frame: 12 month
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 3 Oct 2014.
- Derived from this study: PubMed 25406639Beirer M, Siebenlist S, Cronlein M, Postl L, Huber-Wagner S, Biberthaler P, Kirchhoff C. Clinical and radiological outcome following treatment of displaced lateral clavicle fractures using a locking compression plate with lateral extension: a prospective study. BMC Musculoskelet Disord. 2014 Nov 19;15:380. doi: 10.1186/1471-2474-15-380.
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 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?
An observational study of Fracture, Closed, Comminuted, Healing, 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 2 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: finished, as of the sponsor's last update on 3 Oct 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?
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?
bone healing (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 NCT02256059, 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 3 Oct 2014.