Functional Outcome in Midshaft Clavicle Fracture, Treated With Superior Versus Anteroinferior Reconstruction Plate

Functional Outcome in Midshaft Clavicle Fracture Patients, Treated With Superior Versus Anteroinferior Reconstruction Plate. Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Closed Fracture of Shaft of Clavicle
• Intervention / Treatment: Procedure: Open Reduction Internal Fixation superior plate; Procedure: Open Reduction Internal Fixation anteroinferior plate

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: superior group; this group with midshaft clavicle fracture were treated with superior reconstruction plate	Procedure: Open Reduction Internal Fixation superior plate; 3.5mm superior reconstruction plate
EXPERIMENTAL: anteroinferior group; this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate	Procedure: Open Reduction Internal Fixation anteroinferior plate; 3.5mm anteroinferior reconstruction plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after surgery
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	60 days after surgery
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	90 days after surgery
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	365 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after surgery
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	60 days after surgery
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	90 days after surgery
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	365 days after surgery

Collaborators and Investigators

• Sponsor: UMAE Hospital de Traumatologia y Ortopedia de Puebla
• Investigators: Principal Investigator: Jose A Manrique, MD, UMAE Hospital de Traumatologia y Ortopedia de Puebla; Study Chair: Gustavo Rivera Saldivar, MD, UMAE Hospital de Traumatologia y Ortopedia de Puebla

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2015
• Primary Completion (ACTUAL): September 30, 2017
• Study Completion (ACTUAL): January 15, 2018

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (ACTUAL): May 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: functional outcome; midshaft clavicle fracture; anteroinferior plate; superior plate; reconstruction plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Closed
• Other Study ID Numbers: UMAE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No