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

Clavicle Fracture 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Clinical Trial Details — Status: Withdrawn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: NCT01307670
• Other study ID #: 1109438
• Status: Withdrawn
• Phase: N/A
• First received: December 2, 2008
• Last updated: September 26, 2016
• Start date: April 2008
• Est. completion date: April 2008

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

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 16-80

• Middle third fracture

• Displaced

Exclusion Criteria:

• Ipsilateral shoulder girdle injury

• Open fracture

• Pathologic fracture

• Associated neurologic injury

Study Design

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

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Procedure:
• Operative treatment with intramedullary nailing
Open reduction and internal fixation with intramedullary nailing device
• Operative treatment with plate fixation.
Open reduction and internal fixation with plate and screws.

Locations

Country	Name	City	State
United States	University of Missouri Health Care, Dept of Orthopaedic Surgery	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

Coupe BD, Wimhurst JA, Indar R, Calder DA, Patel AD. A new approach for plate fixation of midshaft clavicular fractures. Injury. 2005 Oct;36(10):1166-71. Epub 2005 Aug 1. — View Citation

Grassi FA, Tajana MS, D'Angelo F. Management of midclavicular fractures: comparison between nonoperative treatment and open intramedullary fixation in 80 patients. J Trauma. 2001 Jun;50(6):1096-100. — View Citation

Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. — View Citation

Jubel A, Andemahr J, Bergmann H, Prokop A, Rehm KE. Elastic stable intramedullary nailing of midclavicular fractures in athletes. Br J Sports Med. 2003 Dec;37(6):480-3; discussion 484. — View Citation

McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH, Wild LM, Potter J. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am. 2006 Jan;88(1):35-40. — View Citation

Poigenfürst J, Rappold G, Fischer W. Plating of fresh clavicular fractures: results of 122 operations. Injury. 1992;23(4):237-41. — View Citation

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.

Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Or — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rates		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	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]).		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	Time to union		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	Union/non-union rate		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	Pain		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	Return to work and activity		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	Radiographic outcome		6, and 12 weeks, and 6 and 12 months	No
Secondary	Cosmesis		2, 6, and 12 weeks, and 6 and 12 months	No
Secondary	Duration of surgery		Postoperatively, if applicable	No
Secondary	Length of incision		Postoperatively, if applicable	No
Secondary	Fluoroscopy time		Postoperatively, if applicable	No
Secondary	Blood loss		Postoperatively, if applicable	No
Secondary	Quality of reduction		Postoperatively, if applicable	No
Secondary	Postoperative pain		Postoperatively, if applicable	No