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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

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

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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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