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Completed

NCT Number: NCT03533634

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

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.

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Key information

Conditions

Closed Fracture of Shaft of Clavicle

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Reduction Internal Fixation superior plate

Procedure

3.5mm superior reconstruction plate

Open Reduction Internal Fixation anteroinferior plate

Procedure

3.5mm anteroinferior reconstruction plate

Primary outcomes

  1. Disabilities of Arm Shoulder and Hand score (DASH)

    Time frame: 30 days after surgery

    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

  2. Disabilities of Arm Shoulder and Hand score (DASH)

    Time frame: 60 days after surgery

    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

  3. Disabilities of Arm Shoulder and Hand score (DASH)

    Time frame: 90 days after surgery

    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

  4. Disabilities of Arm Shoulder and Hand score (DASH)

    Time frame: 365 days after surgery

    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 outcomes

  1. Visual Analogue Scale score (VAS)

    Time frame: 30 days after surgery

    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain

  2. Visual Analogue Scale score (VAS)

    Time frame: 60 days after surgery

    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain

  3. Visual Analogue Scale score (VAS)

    Time frame: 90 days after surgery

    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain

  4. Visual Analogue Scale score (VAS)

    Time frame: 365 days after surgery

    we applied Visual Analogous Scale pain score a 0 to 10 score where 0 is no pain and 10 the maximum grade of pain

Sponsors and collaborators

Lead sponsor

UMAE Hospital de Traumatologia y Ortopedia de Puebla

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 23, 2018
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.