Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

Clavicle Fracture Clinical Trial

Official title:

Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410032
• Other study ID #: IOT-HCFMUSP
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2011
• Last updated: April 25, 2014
• Start date: July 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)

2. Age between 16 and 65 year old;

3. Terms of consent signed by the patient or guardian.

Exclusion Criteria:

1. Fracture of medial or lateral third of the clavicle;

2. Cortical contact between the main fracture fragments;

3. Age below 16 years old or more than 65 years old;

4. Pathological fracture;

5. Ipsilateral previous injuries of the shoulder or upper limb;

6. Ipsilateral associated fractures of the shoulder or upper limb;

7. Neuro-vascular injury associated;

8. Open fracture not eligible for primary internal fixation;

9. Clinical contraindication for surgery;

10. Fracture older than 30 days;

11. Patient not cooperative or ineligible for the follow-up;

12. Lack of consent to participate.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Procedure:
• Plate fixation
Reconstruction plate
• ESIN
ESIN (Elastic Stable Intramedullary Nailing)

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - Department of Orthopedics and Traumatology	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH score	Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)	6 months	No
Secondary	DASH score	Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)	12 months	No
Secondary	Constant-Murley Score	Shoulder functional score (0: worst function; 100: best function)	6 and 12 months PO	No
Secondary	Time to Union	Time necessary to reach complete union measured in weeks	Monthly	No
Secondary	Radiographic residual shortening	Clavicles shortening compared to the contralateral side	6 months	No
Secondary	Patient satisfaction with the treatment	Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.	6 and 12 months	No
Secondary	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	Monthly	Yes