Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Fracture Clinical Trial

Official title:

Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199653
• Other study ID #: TYH6267
• Secondary ID: T102020Z12
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 10, 2010
• Last updated: September 10, 2010
• Start date: August 2004
• Est. completion date: November 2009

Study information

• Verified date: September 2010
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

Description:

Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity.

There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• a completely displaced middle third clavicle fracture, no cortical contact between main fragments

• fresh fracture, treatment within seven days after injury

• age between 18 and 70 years

• provided informed consent

Exclusion Criteria:

• fracture was not dislocated

• multiple injured patient

• associated neurovascular injury, or suspicion of it

• reduced cooperation

• cancer or any severe illness impairing health

• pathological fracture

• treatment seven days after injury

• open fracture

• corticosteroid or immunosuppressive medication

• upper extremity fracture at same time

• an earlier clavicle or shoulder region fracture

• pregnancy

• lack of consent

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
Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.
• Non-operative treatment with arm immobilised to a sling
Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Töölö Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (9)

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

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

McKee MD, Seiler JG, Jupiter JB. The application of the limited contact dynamic compression plate in the upper extremity: an analysis of 114 consecutive cases. Injury. 1995 Dec;26(10):661-6. — View Citation

NEER CS 2nd. Nonunion of the clavicle. J Am Med Assoc. 1960 Mar 5;172:1006-11. — View Citation

Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32. — View Citation

Nowak J, Holgersson M, Larsson S. Can we predict long-term sequelae after fractures of the clavicle based on initial findings? A prospective study with nine to ten years of follow-up. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):479-86. — View Citation

Nowak J, Mallmin H, Larsson S. The aetiology and epidemiology of clavicular fractures. A prospective study during a two-year period in Uppsala, Sweden. Injury. 2000 Jun;31(5):353-8. — 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

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 Orthop Trauma. 2005 Aug;19(7):504-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function	Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.	Three months	No
Primary	Shoulder function	Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.	One year	No
Primary	Shoulder function	Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.	Two years	No
Secondary	Disability of the Arm, Shoulder and Hand (DASH)	The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.	Three months	No
Secondary	Pain at rest and activity	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly.	Three weeks	No
Secondary	Fracture healing	Fracture healing is examined from Xray.	Three months	No
Secondary	Complications	Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.	Continous till two years	Yes
Secondary	Disability of the Arm, Shoulder and Hand (DASH)	The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.	One year	No
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH)	The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.	Two years	No
Secondary	Pain at rest and activity	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly.	Six weeks	No
Secondary	Pain at rest and at activity	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly	Three months	No
Secondary	Pain at rest and at activity	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly	One year	No
Secondary	Pain at rest and at activity	Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly	Two years	No
Secondary	Fracture healing	Fracture healing is examined from Xray.	One year	No
Secondary	Fracture healing	Fracture healing is examined from Xray.	Two years	No