Minimally invasive versus convencional surgery for the treatment of displaced fractures of the clavicle shaft: a randomized multicentric pragmatic clinical trial

Phase 4

• Conditions: Clavicle fracture; clavicle

• Registration Number: RBR-3czz68
• Lead Sponsor: Adriano Fernando Mendes Junior

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-03
• Last Update Posted: 29 May 2023
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

healthy volunteers; both genders; age over 18 years; with displaced fractures of the shaft of the clavicle type 2B according to Robinson's classification; evolution of up to 21 days.

Exclusion Criteria

patients with open fractures of the clavicle; with associated vascular or nerve injuries; with fractures of the shaft of the clavicle with joint extension; with concomitant fractures or dislocations in the shoulder girdle; with other fractures in the same upper limb; with a history of previous fractures in the clavicle; with a history of previous trauma to the shoulder girdle; with pathological fractures; patients with metabolic diseases; patients with congenital deformities on the same limb

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the number of complications of each technique. Complications will be considered cases of superficial or deep infection, hypertrophic scarring, pseudoarthrosis, refracture, implant failure, skin irritation and shoulder pain, except for hypoesthesia. The number of complications is a discrete numerical variable whose values will be accounted for in a twelve-month postoperative follow-up period.;Evaluate the number of re-operations for each technique. Re-operations will be considered for cases that require a new surgical intervention such as deep infection, pseudoarthrosis, refracture, implant failure and scheduled implant removal. The number of re-operations is a discrete numerical variable whose values will be accounted for in a twelve-month period of postoperative follow-up.