Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures

Clavicle Fractures Clinical Trial

Official title:

Comparison of Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01311219
• Other study ID #: 1109438-1
• Status: Withdrawn
• Phase: N/A
• First received: March 1, 2011
• Last updated: September 29, 2016
• Start date: May 2009
• Est. completion date: May 2009

Study information

• Verified date: September 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients with acute, displaced fractures of the middle third of the clavicle will be randomly assigned into either the non-operative treatment group or the operative treatment group. The operative treatment group will be randomly assigned to repair with either an intramedullary device or a plate and screws.

Description:

Patients with acute, displaced fractures of the middle third of the clavicle will be randomly assigned into either the non-operative treatment group or the operative treatment group. The operative treatment group will be randomly assigned to repair with either an intramedullary device or a plate and screws. Pre-operative variables will be accounted for in detail. Operative variables including duration of surgery, length of incision, fluoroscopy times, blood loss, and quality of reduction will be recorded. Patients will be followed with regular post-operative visits in which radiographs and clinical examination will be performed. Outcome variables will include post-operative pain, time to union, union/non-union rate, return to work, return to activity, radiographic outcome, complication rates, incidence of repeat procedures, cosmesis, and functional outcome based on strength, range of motion, and scoring systems. There are five hypotheses for this study: 1) Operative treatment of acute displaced midshaft clavicle fractures will yield better patient-based functional outcomes when compared to nonoperative treatment as measured by physical assessment of strength and range of motion, standardized scoring systems and return to normal daily activities. 2) Operative treatment of acute displaced midshaft clavicle fractures will yield lower radiographically-determined nonunion rates, improved cosmesis and fewer complaints of residual pain when compared to nonoperative treatment. 3) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will be more efficacious than operative treatment with plate fixation as measured by duration of surgery, length of incision, fluoroscopy time, blood loss, and quality of reduction. 4) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will result in fewer complications than operative treatment with plate fixation including; nonunion rate, infection, incidence of repeat procedures, refracture rate, and hardware malfunction. 5) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will yield lower radiographically-determined nonunion rates, improved cosmesis, and fewer complaints of residual pain when compared to operative treatment with plate fixation.

Other known NCT identifiers

• NCT01307670

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria: All candidates with a radiographically confirmed, displaced, midshaft clavicle fracture, between the ages of 16 and 80.

Exclusion Criteria: Patients presenting with ipsilateral shoulder girdle injury, open fracture, pathologic fracture, or associated neurologic injury. Patients who are pregnant and therefore, unable to undergo radiologic assessment. Patients deemed incompetent to make medical decisions regarding their own health care. Patients unwilling or unable to complete postoperative evaluation at 2, 6, and 12 weeks and long term follow-up evaluation at 6 and 12 months. Prisoners who will be difficult to complete follow-up.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clavicle Fractures
• Fractures, Bone

Intervention

Other:
• Non-operative Treatment
A figure-of-8 brace will be applied to afflicted extremity in clinic. The patient will be instructed on proper application of the brace and asked to continue wearing the brace for 2 to 6 weeks, depending on the patient's level of comfort.

Procedure:
• Operative Treatment-Plate Fixation
Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.
• Operative Treatment-Intramedullary Pinning
Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (2)

Böstman O, Manninen M, Pihlajamäki H. Complications of plate fixation in fresh displaced midclavicular fractures. J Trauma. 1997 Nov;43(5):778-83. — View Citation

Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability of the Arm, Shoulder, and Hand (DASH)		2, 6, and 12 weeks and 6 and 12 months	No
Secondary	The Constant Pain Score		2, 6, and 12 weeks and 6 and 12 months	No