Plating Clavicle Fractures

United States Army Institute of Surgical Research90 enrolled

Overview

The anterior-inferior clavicle plate position will have a lower rate of soft tissue irritation that limits activity and/or requires hardware removal compared to superior plate position.

Compare the rates of soft-tissue irritation with two different methods of plating for clavicle fractures. Patients will be randomized to anterior-inferior or superior plating. Validated shoulder scoring systems will be used to assess outcome. Specific follow-up questions will address the patient's ability to wear his/her uniform, body armor, ruck sack, and other shoulder-borne equipment over the surgical site.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Clavicle Fracture, Non Union/Malunion

Interventions

superior platePROCEDURE

Open reduction internal fixation (ORIF) clavicle with superior plate

anterior-inferior platePROCEDURE

ORIF clavicle with anterior inferior plate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Active duty, Reservists, National Guard service members * completely displaced shaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments) * a fracture involving the middle third of the clavicle (a fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment) * chronic nonunion and malunion fractures * no medical contraindications to general anesthesia * provided informed consent. Exclusion Criteria: * an age of less than eighteen years or greater than sixty five years * a fracture in the proximal or distal third of the clavicle not amenable to plating * a pathological fracture * an associated head injury (a Glasgow Coma Scale score of \<15 at 21 days after injury) * an inability to comply with followup * a medical contraindication to surgery and/or anesthesia (such as heart disease, renal failure, or active chemotherapy) * a lack of consent.

Locations (2)

William Beaumont Army Medical Center

El Paso, Texas, United States

US Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Outcomes

Primary Outcomes

Less irritation with anterior-inferior plating and less need for hardware removal.

Time frame: 2 years

Secondary Outcomes

DASH (Disability of Arm, Shoulder and Hand) and constant scores

Time frame: 2 years

Data from ClinicalTrials.gov

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