Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicle Fractures

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fernando Brandao de Andrade e Silva, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01410032
First received: May 23, 2011
Last updated: November 11, 2013
Last verified: November 2013

May 23, 2011
November 11, 2013
July 2010
January 2014   (final data collection date for primary outcome measure)
DASH score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
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).
Complete list of historical versions of study NCT01410032 on ClinicalTrials.gov Archive Site
  • DASH score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
  • Constant-Murley Score [ Time Frame: 6 and 12 months PO ] [ Designated as safety issue: No ]
    Shoulder functional score (0: worst function; 100: best function)
  • Time to Union [ Time Frame: Monthly ] [ Designated as safety issue: No ]
    Time necessary to reach complete union measured in weeks
  • Radiographic residual shortening [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clavicles shortening compared to the contralateral side
  • Patient satisfaction with the treatment [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.
  • Complication rate [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

    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

  • 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.
Not Provided
Not Provided
 
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicle Fractures
Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicle Fractures: a Prospective, Randomized Clinical Trial

The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicle fractures treated with plates or intramedullary flexible nails fixation.

Midshaft clavicle 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, fractures or imminent exposure and associated neurovascular injury.

Plate fixation of midshaft clavicle 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 clavicle fractures, with different reports of 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 clavicle fractures treated with plates or intramedullary flexible nails fixation.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Clavicle Fracture
  • Procedure: Fracture fixation with Plate.
    Reconstruction plates.
  • Procedure: Fracture fixation with intramedullar nailing
    ESIN (Elastic Stable Intramedullary Nailing)
  • Active Comparator: Plate Fixation
    Reconstruction Plate
    Intervention: Procedure: Fracture fixation with Plate.
  • Active Comparator: Intramedullary Nailing
    ESIN (Elastic Stable Intramedullary Nailing)
    Intervention: Procedure: Fracture fixation with intramedullar nailing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
59
July 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01410032
IOT-HCFMUSP
Yes
Fernando Brandao de Andrade e Silva, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Fernando BA Silva, MD University of Sao Paulo - Orthopedic and Traumatology Department
University of Sao Paulo
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP