Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernando B Andrade-Silva, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01410032
First received: May 23, 2011
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Clavicle Fracture
Procedure: Plate fixation
Procedure: ESIN
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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



Enrollment: 59
Study Start Date: July 2010
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plate fixation
Reconstruction plate
Procedure: Plate fixation
Reconstruction plate
Active Comparator: ESIN
ESIN (Elastic Stable Intramedullary Nailing)
Procedure: ESIN
ESIN (Elastic Stable Intramedullary Nailing)

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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01410032

Locations
Brazil
University of Sao Paulo - Department of Orthopedics and Traumatology
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Fernando B Andrade-Silva, MD University of Sao Paulo - Department of Orthopedics and Traumatology
  More Information

No publications provided

Responsible Party: Fernando B Andrade-Silva, MD, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01410032     History of Changes
Other Study ID Numbers: IOT-HCFMUSP
Study First Received: May 23, 2011
Last Updated: April 25, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
clavicle
clavicular
fracture
midshaft
plate
ESIN
intramedullary
flexible
nailing

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 31, 2014