Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
Primary Purpose
Closed Fracture of Shaft of Clavicle
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open Reduction Internal Fixation superior plate
Open Reduction Internal Fixation anteroinferior plate
Sponsored by
About this trial
This is an interventional treatment trial for Closed Fracture of Shaft of Clavicle focused on measuring midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate
Eligibility Criteria
Inclusion Criteria:
- traumatic fracture
- ao 15 b1 and 15 b2
- no previous shoulder lesions
- no further 7 days fractures
- closed fracture
Exclusion Criteria:
- calcium diseases
- Previous shoulder pain
- other fractures associated
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
superior group
anteroinferior group
Arm Description
this group with midshaft clavicle fracture were treated with superior reconstruction plate
this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate
Outcomes
Primary Outcome Measures
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Disabilities of Arm Shoulder and Hand score (DASH)
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Secondary Outcome Measures
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Visual Analogue Scale score (VAS)
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Full Information
NCT ID
NCT03533634
First Posted
April 30, 2018
Last Updated
May 10, 2018
Sponsor
UMAE Hospital de Traumatologia y Ortopedia de Puebla
1. Study Identification
Unique Protocol Identification Number
NCT03533634
Brief Title
Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
Official Title
Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
January 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMAE Hospital de Traumatologia y Ortopedia de Puebla
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques. the first one was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle. the patients had the same rehabilitation program and evaluated with functional scores at 30, 60, 90 and 365 days after surgery. biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
Detailed Description
The purpose of this study was to evaluate the functional outcome in patients with a midshaft clavicle fracture treated with to different techniques.
the first technique was placing a 3.5mm reconstruction plate in the superior side of the clavicle and the second one placing the same 3.5mm reconstruction plate in the anteroinferior side of the clavicle.
the patients had the same rehabilitation program and evaluated with Disabilities Arm Shoulder and Hand functional outcome score and Visual Analogue Score for pain at 30, 60, 90 and 365 days after surgery.
biomechanical studies have demonstrated more stable construct using an anteroinferior plate in clavicle fractures and we were trying to find out if it has a clinical relevance in patients with midshaft clavicle fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture of Shaft of Clavicle
Keywords
midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinical trial
Masking
ParticipantOutcomes Assessor
Masking Description
the patient and the outcomes analyzer were masked
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
superior group
Arm Type
Experimental
Arm Description
this group with midshaft clavicle fracture were treated with superior reconstruction plate
Arm Title
anteroinferior group
Arm Type
Experimental
Arm Description
this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate
Intervention Type
Procedure
Intervention Name(s)
Open Reduction Internal Fixation superior plate
Intervention Description
3.5mm superior reconstruction plate
Intervention Type
Procedure
Intervention Name(s)
Open Reduction Internal Fixation anteroinferior plate
Intervention Description
3.5mm anteroinferior reconstruction plate
Primary Outcome Measure Information:
Title
Disabilities of Arm Shoulder and Hand score (DASH)
Description
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Time Frame
30 days after surgery
Title
Disabilities of Arm Shoulder and Hand score (DASH)
Description
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Time Frame
60 days after surgery
Title
Disabilities of Arm Shoulder and Hand score (DASH)
Description
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Time Frame
90 days after surgery
Title
Disabilities of Arm Shoulder and Hand score (DASH)
Description
we applied the Disabilities of arm, shoulder and hand score a score from 0 to 100 where 0 is no disability and 100 the worst disability
Time Frame
365 days after surgery
Secondary Outcome Measure Information:
Title
Visual Analogue Scale score (VAS)
Description
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Time Frame
30 days after surgery
Title
Visual Analogue Scale score (VAS)
Description
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Time Frame
60 days after surgery
Title
Visual Analogue Scale score (VAS)
Description
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Time Frame
90 days after surgery
Title
Visual Analogue Scale score (VAS)
Description
we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain
Time Frame
365 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
traumatic fracture
ao 15 b1 and 15 b2
no previous shoulder lesions
no further 7 days fractures
closed fracture
Exclusion Criteria:
calcium diseases
Previous shoulder pain
other fractures associated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Manrique, MD
Organizational Affiliation
UMAE Hospital de Traumatologia y Ortopedia de Puebla
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gustavo Rivera Saldivar, MD
Organizational Affiliation
UMAE Hospital de Traumatologia y Ortopedia de Puebla
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate
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