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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03533634

Enrollment

Registered

2018-05-23

Start date

2015-03-01

Completion date

2018-01-15

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Closed Fracture of Shaft of Clavicle

Keywords

midshaft clavicle fracture, functional outcome, anteroinferior plate, superior plate, reconstruction plate

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.

Interventions

PROCEDUREOpen Reduction Internal Fixation superior plate

3.5mm superior reconstruction plate

PROCEDUREOpen Reduction Internal Fixation anteroinferior plate

3.5mm anteroinferior reconstruction plate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

the patient and the outcomes analyzer were masked

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Disabilities of Arm Shoulder and Hand score (DASH)	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

Secondary

Measure	Time frame	Description
Visual Analogue Scale score (VAS)	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026