Fixation of Midshaft Fractures of the Clavicle With Plate and Intramedullary Flexible Nail
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Purpose
The purpose of this study is to compare the clinical and radiographic results of patients with fractures of the middle clavicle treated by the techniques of fixation with plates and intramedullary flexible nails.
| Condition | Intervention | Phase |
|---|---|---|
|
Fracture of Shaft of Clavicle |
Procedure: Fracture fixation with Plate. Procedure: Fracture fixation with intramedullar nailing |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Fixation of Midshaft Fractures of the Clavicle With Plate and Intramedullary Flexible Nail: Randomized Comparative Clinical Trial |
- Functional Outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]Functional outcome accessed by Constant score and DASH score (Disabilities of the Arm, Shoulder and Hand Score).
- Fracture Healing Time [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Time spent until complete bone healing.
- Residual shortening of the clavicle [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The length of both clavicles is compared.
- Implant Failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Number of cases of implant failure in each group.
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Plate Fixation
Reconstruction Plate
|
Procedure: Fracture fixation with Plate.
Reconstruction plates.
|
|
Active Comparator: Intramedullary Nailing
ESIN (Elastic Stable Intramedullary Nailing)
|
Procedure: Fracture fixation with intramedullar nailing
ESIN (Elastic Stable Intramedullary Nailing)
|
Detailed Description:
Midshaft fractures of the clavicle are classically treated by non-surgical methods, with literature reports of high rates of good results. However, different researches have shown higher rates of nonunion and functional complaints related to malunion of clavicular fractures. Currently, indications for surgical treatment have become more frequent and are mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, fractures or imminent exposure and associated neurovascular injury.
The use of plates in the treatment of midshaft fractures of the clavicle is widely described in literature. It is regarded by many as the gold standard, being associated with a high union rate and low complication rate. Among the types of plates used are the reconstruction plates, dynamic compression plates (DCP) or low-contact dynamic compression plates (LC-DCP), semi-tubular plates, pre-molded plates and plates with angular stability. Among the main complications reported are postoperative infection, loosening of material synthesis, numbness at the incision, damage to neurovascular structures, pseudoarthrosis and discomfort at the surgical site by the presence of the plate.
The use of titanium elastic nails for fixation of fractures of the clavicle has received increased attention in recent years and various authors have reported their experience with this type of synthesis. One suggested advantage is the support given by the 3-point flexible nail, which provides good biomechanics resistance, and uses the principle of relative stability, favoring callus formation. Compared with plain steel wire, have a lower risk of migration, since they have greater flexibility and better bone fixation.
The purpose of this study is to compare the clinical and radiographic results of patients with fractures of the middle clavicle treated by the techniques of fixation with plates and intramedullary flexible nails.
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Contacts and Locations| Contact: Fernando BA Silva, MD | 55-11-83729983 | fbrandao86@yahoo.com.br |
| Brazil | |
| University of Sao Paulo - Orthopedic and Traumatology Department | Recruiting |
| Sao Paulo, Brazil, 05403-010 | |
| Contact: Fernando BA Silva, MD 55-11-83729983 fbrandao86@yahoo.com.br | |
| Principal Investigator: Fernando BA Silva, MD | |
| Principal Investigator: | Fernando BA Silva, MD | University of Sao Paulo - Orthopedic and Traumatology Department |
More Information
No publications provided
| Responsible Party: | Fernando B A Silva, University of Sao Paulo - Orthopedics and Traumatology Department |
| ClinicalTrials.gov Identifier: | NCT01410032 History of Changes |
| Other Study ID Numbers: | IOT-HCFMUSP |
| Study First Received: | May 23, 2011 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by University of Sao Paulo:
|
clavicle fracture plate |
TEN ESIN intramedullar |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013