Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

NCT ID: NCT01410032

Last Updated: 2014-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-04-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plate fixation

Reconstruction plate

Group Type: ACTIVE_COMPARATOR

Plate fixation

Intervention Type: PROCEDURE

Reconstruction plate

ESIN

ESIN (Elastic Stable Intramedullary Nailing)

Group Type: ACTIVE_COMPARATOR

ESIN

Intervention Type: PROCEDURE

ESIN (Elastic Stable Intramedullary Nailing)

Interventions

Plate fixation

Reconstruction plate

Intervention Type: PROCEDURE

ESIN

ESIN (Elastic Stable Intramedullary Nailing)

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fernando B Andrade-Silva, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando B Andrade-Silva, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo - Department of Orthopedics and Traumatology

Locations

University of Sao Paulo - Department of Orthopedics and Traumatology

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 25878305 (View on PubMed)

Other Identifiers

IOT-HCFMUSP

Identifier Type: -

Identifier Source: org_study_id