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

NCT ID: NCT01311219

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-05-31

Brief 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.

Detailed 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.

Conditions

Clavicle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No surgery

Non-operative Treatment

Group Type: ACTIVE_COMPARATOR

Non-operative Treatment

Intervention Type: OTHER

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.

Plate fixation

Operative Treatment-Plate fixation

Group Type: ACTIVE_COMPARATOR

Operative Treatment-Plate Fixation

Intervention Type: PROCEDURE

Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.

Intramedullary pinning

Operative Treatment-Intramedullary Pinning

Group Type: ACTIVE_COMPARATOR

Operative Treatment-Intramedullary Pinning

Intervention Type: PROCEDURE

Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).

Interventions

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.

Intervention Type: OTHER

Operative Treatment-Plate Fixation

Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.

Intervention Type: PROCEDURE

Operative Treatment-Intramedullary Pinning

Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard A White, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri-Columbia

Columbia, Missouri, United States

Countries

United States

References

Bostman O, Manninen M, Pihlajamaki H. Complications of plate fixation in fresh displaced midclavicular fractures. J Trauma. 1997 Nov;43(5):778-83. doi: 10.1097/00005373-199711000-00008.

Reference Type: BACKGROUND

PMID: 9390489 (View on PubMed)

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. doi: 10.2106/JBJS.F.00020.

Reference Type: BACKGROUND

PMID: 17200303 (View on PubMed)

Other Identifiers

1109438-1

Identifier Type: -

Identifier Source: org_study_id

NCT01307670

Identifier Type: -

Identifier Source: nct_alias