Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures - Full Text View

Purpose

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

Condition	Intervention	Phase
Clavicle Fracture	Procedure: Operative treatment Procedure: Non-operative treatment with arm immobilised to a sling	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:

Shoulder function [ Time Frame: Three months ] [ Designated as safety issue: No ]
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.
Shoulder function [ Time Frame: One year ] [ Designated as safety issue: No ]
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.
Shoulder function [ Time Frame: Two years ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: Three months ] [ Designated as safety issue: No ]
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.
Pain at rest and activity [ Time Frame: Three weeks ] [ Designated as safety issue: No ]
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.
Fracture healing [ Time Frame: Three months ] [ Designated as safety issue: No ]
Fracture healing is examined from Xray.
Complications [ Time Frame: Continous till two years ] [ Designated as safety issue: Yes ]
Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.
Disability of the Arm, Shoulder and Hand (DASH) [ Time Frame: One year ] [ Designated as safety issue: No ]
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.
Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: Two years ] [ Designated as safety issue: No ]
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.
Pain at rest and activity [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
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.
Pain at rest and at activity [ Time Frame: Three months ] [ Designated as safety issue: No ]
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
Pain at rest and at activity [ Time Frame: One year ] [ Designated as safety issue: No ]
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
Pain at rest and at activity [ Time Frame: Two years ] [ Designated as safety issue: No ]
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
Fracture healing [ Time Frame: One year ] [ Designated as safety issue: No ]
Fracture healing is examined from Xray.
Fracture healing [ Time Frame: Two years ] [ Designated as safety issue: No ]
Fracture healing is examined from Xray.

Enrollment:	60
Study Start Date:	August 2004
Study Completion Date:	November 2009
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199653

Locations

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

Sponsors and Collaborators

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

More Information

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.

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.

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.

Neer, C. S., 2nd: Nonunion of the clavicle. J Am Med Assoc, 172: 1006-11, 1960

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

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.

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.

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

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.

Responsible Party:	Kaisa Virtanen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:	NCT01199653 History of Changes
Other Study ID Numbers:	TYH6267, T102020Z12
Study First Received:	September 10, 2010
Last Updated:	September 10, 2010
Health Authority:	Finland: Ethics Committee

Keywords provided by Helsinki University Central Hospital:

clavicle fractures
midshaft
dislocated
operative treatment

conservative treatment
non-operative treatment
randomized controlled trial
bone plates

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013