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Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

Primary Purpose

Clavicle Fracture

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Plate fixation
ESIN
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle Fracture focused on measuring clavicle, clavicular, fracture, midshaft, plate, ESIN, intramedullary, flexible, nailing

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo - Department of Orthopedics and Traumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plate fixation

ESIN

Arm Description

Reconstruction plate

ESIN (Elastic Stable Intramedullary Nailing)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

DASH score
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Constant-Murley Score
Shoulder functional score (0: worst function; 100: best function)
Time to Union
Time necessary to reach complete union measured in weeks
Radiographic residual shortening
Clavicles shortening compared to the contralateral side
Patient satisfaction with the treatment
Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.
Complication rate
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

Full Information

First Posted
May 23, 2011
Last Updated
April 25, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01410032
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture
Keywords
clavicle, clavicular, fracture, midshaft, plate, ESIN, intramedullary, flexible, nailing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plate fixation
Arm Type
Active Comparator
Arm Description
Reconstruction plate
Arm Title
ESIN
Arm Type
Active Comparator
Arm Description
ESIN (Elastic Stable Intramedullary Nailing)
Intervention Type
Procedure
Intervention Name(s)
Plate fixation
Intervention Description
Reconstruction plate
Intervention Type
Procedure
Intervention Name(s)
ESIN
Intervention Description
ESIN (Elastic Stable Intramedullary Nailing)
Primary Outcome Measure Information:
Title
DASH score
Description
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
DASH score
Description
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
Time Frame
12 months
Title
Constant-Murley Score
Description
Shoulder functional score (0: worst function; 100: best function)
Time Frame
6 and 12 months PO
Title
Time to Union
Description
Time necessary to reach complete union measured in weeks
Time Frame
Monthly
Title
Radiographic residual shortening
Description
Clavicles shortening compared to the contralateral side
Time Frame
6 months
Title
Patient satisfaction with the treatment
Description
Subjective measurement. Patients are questioned about their satisfaction with the treatment instituted. Binary outcome.
Time Frame
6 and 12 months
Title
Complication rate
Description
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
Time Frame
Monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando B Andrade-Silva, MD
Organizational Affiliation
University of Sao Paulo - Department of Orthopedics and Traumatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo - Department of Orthopedics and Traumatology
City
Sao Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25878305
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.
Results Reference
derived

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Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures

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