Clavicle FracturePhase 2NCT01410032
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
A Phase 2 study testing Plate fixation and ESIN in people with Clavicle Fracture, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Plate fixation and ESIN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Apr 2014
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
- Age between 16 and 65 year old;
- Terms of consent signed by the patient or guardian.
Who cannot join
- Fracture of medial or lateral third of the clavicle;
- Cortical contact between the main fracture fragments;
- Age below 16 years old or more than 65 years old;
- Pathological fracture;
- Ipsilateral previous injuries of the shoulder or upper limb;
- Ipsilateral associated fractures of the shoulder or upper limb;
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- Neuro-vascular injury associated;
- Open fracture not eligible for primary internal fixation;
- Clinical contraindication for surgery;
- Fracture older than 30 days;
- Patient not cooperative or ineligible for the follow-up;
- Lack of consent to participate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo - Department of Orthopedics and Traumatology
São Paulo, São Paulo, 05403-010
About this study
Official title: Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.
Read the detailed description
Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury.
Plate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms.
Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation.
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.
- Conditions
- Clavicle Fracture
- Being tested
- Plate fixation, ESIN
- Keywords
- clavicle, clavicular, fracture, midshaft, plate, ESIN, intramedullary, flexible, nailing
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate fixationProcedure or surgery
Reconstruction plate
ESINProcedure or surgery
ESIN (Elastic Stable Intramedullary Nailing)
| Study group | Role | What they receive |
|---|---|---|
| Plate fixation | Active comparator | Reconstruction plate Receives: Procedure: Plate fixation |
| ESIN | Active comparator | ESIN (Elastic Stable Intramedullary Nailing) Receives: Procedure: ESIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH score
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Measured: 6 months
Secondary outcomes (6)
DASH score
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Measured: 12 months
Constant-Murley Score
Shoulder functional score (0: worst function; 100: best function)
Measured: 6 and 12 months PO
Time to Union
Time necessary to reach complete union measured in weeks
Measured: Monthly
Radiographic residual shortening
Clavicles shortening compared to the contralateral side
Measured: 6 months
Patient satisfaction with the treatment
Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.
Measured: 6 and 12 months
Complication rate
Complications were divided in Minor and Major, as follows:
Minor: paresthesia, transient neurologic deficit, implant deformation, partial implant migration, acromioclavicular or sternoclavicular pain, hardware related pain
Major: permanent neurologic deficit, total implant failure, total implant migration, refracture, reoperation, nonunion
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2014
- Study completionApr 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 Clavicle FractureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando B Andrade-Silva, MD, University of Sao Paulo
- Investigators
- Fernando B Andrade-Silva, MD, Principal investigator, University of Sao Paulo - Department of Orthopedics and Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410032
- Sponsor's protocol ID
- IOT-HCFMUSP
- Status last verified
- Apr 2014
- First submitted
- 23 May 2011
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497.
PubMed 25878305
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01410032
- Acronym / sponsor ID
- IOT-HCFMUSP
- Conditions
- Clavicle Fracture
- Keywords
- clavicle, clavicular, fracture, midshaft, plate, ESIN, intramedullary, flexible
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Aug 2011 (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 compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.
Detailed description
Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury.
Plate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms.
Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation.
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plate fixation | Active comparator | Procedure: Plate fixationReconstruction plate |
| ESIN | Active comparator | Procedure: ESINESIN (Elastic Stable Intramedullary Nailing) |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
- Age between 16 and 65 year old;
- Terms of consent signed by the patient or guardian.
Key exclusion criteria (12 listed)
- Fracture of medial or lateral third of the clavicle;
- Cortical contact between the main fracture fragments;
- Age below 16 years old or more than 65 years old;
- Pathological fracture;
- Ipsilateral previous injuries of the shoulder or upper limb;
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 fixationReconstruction plate | Procedure or surgery | Plate fixation |
| ESINESIN (Elastic Stable Intramedullary Nailing) | Procedure or surgery | ESIN |
Primary outcome
DASH score
Time frame: 6 months
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
6 secondary outcomes
DASH score
Time frame: 12 months
Constant-Murley Score
Time frame: 6 and 12 months PO
Time to Union
Time frame: Monthly
Radiographic residual shortening
Time frame: 6 months
Patient satisfaction with the treatment
Time frame: 6 and 12 months
Complication rate
Time frame: Monthly
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 28 Apr 2014.
- Derived from this study: PubMed 25878305Andrade-Silva FB, Kojima KE, Joeris A, Santos Silva J, Mattar R Jr. Single, superiorly placed reconstruction plate compared with flexible intramedullary nailing for midshaft clavicular fractures: a prospective, randomized controlled trial. J Bone Joint Surg Am. 2015 Apr 15;97(8):620-6. doi: 10.2106/JBJS.N.00497.
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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.
Fernando B Andrade-Silva, MD principal investigator
University of Sao Paulo - Department of Orthopedics and Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plate fixation and ESIN in people with Clavicle Fracture, run by University of Sao Paulo at 1 site in Brazil.
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 12 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 28 Apr 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
DASH score (time frame: 6 months). 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 NCT01410032, 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 28 Apr 2014.