Clinical trial NCT03533634: 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
Overall status: COMPLETED
Phase: NA
Conditions: Closed Fracture of Shaft of Clavicle
Keywords: midshaft clavicle fracture
functional outcome
anteroinferior plate
superior plate
reconstruction plate
Lead sponsor: UMAE Hospital de Traumatologia y Ortopedia de Puebla
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disabilities of Arm Shoulder and Hand score (DASH)
timeFrame: 30 days after surgery
measure: Disabilities of Arm Shoulder and Hand score (DASH)
timeFrame: 60 days after surgery
measure: Disabilities of Arm Shoulder and Hand score (DASH)
timeFrame: 90 days after surgery
measure: Disabilities of Arm Shoulder and Hand score (DASH)
timeFrame: 365 days after surgery
Secondary outcomes:
measure: Visual Analogue Scale score (VAS)
timeFrame: 30 days after surgery
measure: Visual Analogue Scale score (VAS)
timeFrame: 60 days after surgery
measure: Visual Analogue Scale score (VAS)
timeFrame: 90 days after surgery
measure: Visual Analogue Scale score (VAS)
timeFrame: 365 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: UMAE Hospital de Traumatologia y Ortopedia de Puebla
name: Jose A Manrique, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMAE Hospital de Traumatologia y Ortopedia de Puebla
name: Gustavo Rivera Saldivar, MD
role: STUDY_CHAIR
References: