Comparison of Nailing, Plate Fixation and Non-operative Treatment of Midshaft Clavicle Fractures

This study has been withdrawn prior to enrollment.
(duplicate entry)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01307670
First received: December 2, 2008
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

Until recently, clavicle fractures have been treated mainly with a sling or brace and felt to have favorable outcomes. Recently, however, data has been published suggesting that these injuries are not as harmless as once thought and, if treated without surgery, may result in lasting functional deficits. As a result, surgery for clavicle fractures is becoming increasingly more accepted as a better treatment option. There are two basic methods of operative treatment. The first involves placement of a metal rod within the middle of the clavicle through a small incision in the skin. Proponents of this technique believe that it has improved cosmetic outcome because of a smaller incision, less post operative pain, and possibly a faster return to activity when compared to other surgical treatments. The second method involves making a larger incision over the clavicle, exposing a large portion of the bone, and fixing the fracture with a plate and screws. Proponents of this method cite better stablity and a decreased risk of the hardware migrating from its intended position among other advantages. This study would propose to determine if these two methods of fracture fixation are necessary and if so, which would provide better outcomes following their use in selected patients.


Condition Intervention
Fracture of Clavicle
Procedure: Operative treatment with intramedullary nailing
Procedure: Operative treatment with plate fixation.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Intramedullary Nailing, Plate Fixation and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Complication rates [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Shoulder function as assessed by strength, range of motion and scoring systems (Disability of the Arm, Shoulder, and Hand [DASH] , Constant Pain Score, and Short Form Health Survey [SF-36]). [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Time to union [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Union/non-union rate [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Return to work and activity [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Radiographic outcome [ Time Frame: 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Cosmesis [ Time Frame: 2, 6, and 12 weeks, and 6 and 12 months ] [ Designated as safety issue: No ]
  • Duration of surgery [ Time Frame: Postoperatively, if applicable ] [ Designated as safety issue: No ]
  • Length of incision [ Time Frame: Postoperatively, if applicable ] [ Designated as safety issue: No ]
  • Fluoroscopy time [ Time Frame: Postoperatively, if applicable ] [ Designated as safety issue: No ]
  • Blood loss [ Time Frame: Postoperatively, if applicable ] [ Designated as safety issue: No ]
  • Quality of reduction [ Time Frame: Postoperatively, if applicable ] [ Designated as safety issue: No ]
  • Postoperative pain [ Time Frame: Postoperatively, if applicable ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Nonoperative treatment with conventional arm sling or brace.
Active Comparator: 2
Operative treatment with intramedullary pinning
Procedure: Operative treatment with intramedullary nailing
Open reduction and internal fixation with intramedullary nailing device
Other Names:
  • Rockwood pin
  • Pinning
  • Nails
Active Comparator: 3
Operative treatment with plate fixation
Procedure: Operative treatment with plate fixation.
Open reduction and internal fixation with plate and screws.
Other Names:
  • Plate
  • Plate and screw

Detailed Description:

Poor results following non-operative treatment of displaced midshaft clavicle fractures have been described by several authors. McKee et al(2006) presented 30 patients with displaced midshaft clavicle fractures treated nonoperatively. At a mean follow up of 55 months, only 18 had returned to their preinjury levels of work and recreational activity. Mean DASH and Constant shoulder scores were significantly inferior to the normal population. Hill et al (1997) reviewd 52 cases of completely displaced middle third clavicle fractures at a mean follow up of 38 months. They report a nonunion rate of 15% and 31% overall unsatisfactory results. Poor results were related to residual pain, brachial plexus irritation, and cosmetic complaints. In a systematic review including 771 displaced midshaft fractures, Zlodowski (2005) noted a non-union rate of 15% following nonoperative treatment. Nonunion rates following operative treatment were 2% and 2.2% respectively for intramedullary nailing and plate fixation.

Several authors are have presented favorable results following intramedullary nailing of acute clavicle fractures. In a nonrandomized study comparing intramedulllary nailing versus plating versus nonoperative treatment of displaced fractures, Thyagarajan et al (2005)noted no nonunions in the operative group and a 24% nonunion rate in the nonoperative group. Patients treated with an intramedullary device had shorter hospital stays, earlier mobilization and less scar-related pain when compared to those treated with a plate. Four of 17 (24%)patients treated with a plate developed scar related pain and 18% had prominent hardware. Jubel et al (2003) treated 58 markedly displaced fractures in 55 patients with an intramedullary titianium nail. There was a single nonunion and there were no infections, implant displacements or refractures. Patients experienced marked postoperative pain reduction. In a subset of 12 athletes treated under this protocol, these athletes resumed training at a mean 5.9 days and returned to competition at 16.9 days. However, Judd et al (2005) and Grassi et al (1999) report inferior results associated with intramedullary fixation when compared to nonoperative treatment, citing high complications rates with intramedullary nails and acceptable results following nonoperative treatment.

Numerous authors have published data regarding plate fixation of acute clavicle fractures. Smith et al (2001) conducted a randomized clinical trial comparing plating and nonoperative treatment of 100% displaced midshaft clavicle fracures. They report a nonunion rate of 24% (12/50) in the nonoperative group and 0% (0/50) nonunion rate in the operative group. Additionally, 30% of the patients in the nonoperative group reported upper extremity neurologic complaints with overhead activities and 44% reported cosmetic complaints. However, 30% of patients in the operative group requested hardware removal. Poigenfurst et al (1992) treated a total of 131 clavicle fractures in 129 patients. They experienced no bony infections. Four clavicles refractured after removal of the plate and five operations led to pseudarthroses which were successfully treated by reoperation. Despite these complications, they state that the radiological and clinical results in the majority of patients were excellent. Bostman et al (1997)reported on the complications associated with plating of midhaft clavicle fractures, noting 23% complications rate while treating 103 fractures. These complications included deep infection, plate breakage, and refracture following plate removal. Coupe et al (2005) suggest that such a high complication rate may be avoided using an infraclavicular approach to the clavicle. In their series of 89 patients treated in this manner, they report only two major complications and six minor complications.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 16-80
  • Middle third fracture
  • Displaced

Exclusion Criteria:

  • Ipsilateral shoulder girdle injury
  • Open fracture
  • Pathologic fracture
  • Associated neurologic injury
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307670

Locations
United States, Missouri
University of Missouri Health Care, Dept of Orthopaedic Surgery
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Richard A White, MD University of Missouri - Columbia, Dept of Orthopaedic Surgery
  More Information

Publications:
Thyagarajan D, Day M, Dent C, Williams R, Evans R. Treatment of displaced midclavicular fractures with rockwood pin. J Bone Joint Surg Br 2005 87-B: 165.

Responsible Party: Richard Alexander White, MD, University of Missouri, Dept of Orthopaedic Surgery
ClinicalTrials.gov Identifier: NCT01307670     History of Changes
Other Study ID Numbers: 1109438
Study First Received: December 2, 2008
Last Updated: March 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
acute
midclavicular
displaced
operative therapy
nonoperative therapy
fracture

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014