Clinical trial NCT01410032: Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures
Official title: Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clavicle Fracture
Keywords: clavicle
clavicular
fracture
midshaft
plate
ESIN
intramedullary
flexible
nailing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: DASH score
timeFrame: 6 months
Secondary outcomes:
measure: DASH score
timeFrame: 12 months
measure: Constant-Murley Score
timeFrame: 6 and 12 months PO
measure: Time to Union
timeFrame: Monthly
measure: Radiographic residual shortening
timeFrame: 6 months
measure: Patient satisfaction with the treatment
timeFrame: 6 and 12 months
measure: Complication rate
timeFrame: Monthly
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo - Department of Orthopedics and Traumatology
Study officials:
affiliation: University of Sao Paulo - Department of Orthopedics and Traumatology
name: Fernando B Andrade-Silva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.