Plating Clavicle Fractures

Clavicle Fracture, Non Union/Malunion Clinical Trial

Official title:

Does Anterior-Inferior Clavicle Plating Have a Lower Rate of Soft Tissue Irritation Compared to Superior Plating? A Prospective Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00871468
• Other study ID #: H-08-003
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2009
• Last updated: October 11, 2017
• Start date: October 2008
• Est. completion date: August 2018

Study information

• Verified date: December 2016
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clavicle Fracture, Non Union/Malunion
• Fractures, Bone
• Fractures, Ununited

Intervention

Procedure:
• superior plate
Open reduction internal fixation (ORIF) clavicle with superior plate
• anterior-inferior plate
ORIF clavicle with anterior inferior plate

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research	William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Less irritation with anterior-inferior plating and less need for hardware removal.		2 years
Secondary	DASH (Disability of Arm, Shoulder and Hand) and constant scores		2 years