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Completed

NCT Number: NCT01410032

Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Sao Paulo - Department of Orthopedics and Traumatology

São Paulo, 05403-010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plate fixation

Procedure

Reconstruction plate

ESIN

Procedure

ESIN (Elastic Stable Intramedullary Nailing)

Primary outcomes

  1. DASH score

    Time frame: 6 months

    Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)

Secondary outcomes

  1. DASH score

    Time frame: 12 months

    Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)

  2. Constant-Murley Score

    Time frame: 6 and 12 months PO

    Shoulder functional score (0: worst function; 100: best function)

  3. Time to Union

    Time frame: Monthly

    Time necessary to reach complete union measured in weeks

  4. Radiographic residual shortening

    Time frame: 6 months

    Clavicles shortening compared to the contralateral side

  5. Patient satisfaction with the treatment

    Time frame: 6 and 12 months

    Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.

  6. Complication rate

    Time frame: Monthly

    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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 4, 2011
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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