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CompletedNCT03533634Updated May 23, 2018

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

An interventional study of Open Reduction Internal Fixation superior plate and Open Reduction Internal Fixation anteroinferior plate in Closed Fracture of Shaft of Clavicle, sponsored by UMAE Hospital de Traumatologia y Ortopedia de Puebla. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-05-23.

Sponsored by UMAE Hospital de Traumatologia y Ortopedia de Puebla · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Mar 2015, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Closed Fracture of Shaft of Clavicle

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Keywords

  • midshaft clavicle fracture
  • functional outcome
  • anteroinferior plate
  • superior plate
  • reconstruction plate
03

In context

Fractures, Closed

44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.

This study's enrollment of 28 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.

Browse Fractures, Closed studies →

Lead sponsor

This is the only study on the registry with UMAE Hospital de Traumatologia y Ortopedia de Puebla as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • traumatic fracture
  • ao 15 b1 and 15 b2
  • no previous shoulder lesions
  • no further 7 days fractures
  • closed fracture

Exclusion criteria

Exclusion Criteria:

  • calcium diseases
  • Previous shoulder pain
  • other fractures associated
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    superior group

    this group with midshaft clavicle fracture were treated with superior reconstruction plate

    Procedure: Open Reduction Internal Fixation superior plate

  • Experimental
    anteroinferior group

    this group with midshaft clavicle fracture were treated with anteroinferior reconstruction plate

    Procedure: Open Reduction Internal Fixation anteroinferior plate

Interventions

  • ProcedureOpen Reduction Internal Fixation superior plate

    3.5mm superior reconstruction plate

  • ProcedureOpen Reduction Internal Fixation anteroinferior plate

    3.5mm anteroinferior reconstruction plate

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days after surgery

  2. 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

    Time frame: 60 days after surgery

  3. 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

    Time frame: 90 days after surgery

  4. 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

    Time frame: 365 days after surgery

Secondary outcomes

  1. 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

    Time frame: 30 days after surgery

  2. 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

    Time frame: 60 days after surgery

  3. 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

    Time frame: 90 days after surgery

  4. 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

    Time frame: 365 days after surgery

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03533634
Lead sponsor
UMAE Hospital de Traumatologia y Ortopedia de Puebla
Responsible party
Jose Antonio Manrique (Principal Investigator, UMAE Hospital de Traumatologia y Ortopedia de Puebla) — Principal investigator
First posted
May 23, 2018
Start date
Mar 1, 2015
Primary completion
Sep 30, 2017
Completion
Jan 15, 2018
Last update
May 23, 2018

Study contacts

Jose A Manrique, MD
principal investigator · UMAE Hospital de Traumatologia y Ortopedia de Puebla
Gustavo Rivera Saldivar, MD
study chair · UMAE Hospital de Traumatologia y Ortopedia de Puebla

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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