Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

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

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

Study Overview

• Status: Completed
• Conditions: Fracture; Clavicle
• Intervention / Treatment: Procedure: Non-operative treatment with arm immobilised to a sling; Procedure: Operative treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00260
      • Helsinki University Central Hospital, Töölö Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-operative treatment; Non-operative (conservative) treatment of the clavicle fracture	Procedure: Non-operative treatment with arm immobilised to a sling; Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Active Comparator: Operative treatment; Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Fracture healing	Fracture healing is examined from Xray.	Three months
Complications	Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.	Continous till two years
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
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
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
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
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
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
Fracture healing	Fracture healing is examined from Xray.	One year
Fracture healing	Fracture healing is examined from Xray.	Two years

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Kaisa J Virtanen, MD, Helsinki Uiversity Central Hospital; Study Chair: Ville Remes, MD PhD, Helsinki University Central Hospital; Study Chair: Jarkko Pajarinen, MD PhD, Helsinki University Central Hospital; Study Chair: Vesa Savolainen, MD PhD, Helsinki University Central Hospital; Study Chair: Jan-Magnus Björkenheim, MD PhD, Helsinki University Central Hospital; Study Director: Mika P Paavola, MD PhD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1302/0301-620x.79b4.7529.
• 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. doi: 10.1016/0020-1383(95)00148-4.
• NEER CS 2nd. Nonunion of the clavicle. J Am Med Assoc. 1960 Mar 5;172:1006-11. doi: 10.1001/jama.1960.03020100014003. No abstract available.
• Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32.
• 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. doi: 10.1016/j.jse.2004.01.026.
• 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. doi: 10.1016/s0020-1383(99)00312-5.
• Poigenfurst J, Rappold G, Fischer W. Plating of fresh clavicular fractures: results of 122 operations. Injury. 1992;23(4):237-41. doi: 10.1016/s0020-1383(05)80006-3.
• 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. doi: 10.1097/01.bot.0000172287.44278.ef.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 10, 2010
• First Posted (Estimate): September 13, 2010

Study Record Updates

• Last Update Posted (Estimate): September 13, 2010
• Last Update Submitted That Met QC Criteria: September 10, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: randomized controlled trial; conservative treatment; non-operative treatment; clavicle fractures; operative treatment; midshaft; dislocated; bone plates
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: TYH6267; T102020Z12 (Other Identifier: Helsinki University Central Hospital)