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Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

Primary Purpose

Clavicle, Fracture

Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Operative treatment
Non-operative treatment with arm immobilised to a sling
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clavicle focused on measuring clavicle fractures, midshaft, dislocated, operative treatment, conservative treatment, non-operative treatment, randomized controlled trial, bone plates

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital, Töölö Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Non-operative treatment

Operative treatment

Arm Description

Non-operative (conservative) treatment of the clavicle fracture

Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Fracture healing
Fracture healing is examined from Xray.
Complications
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)
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)
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
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
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
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
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
Fracture healing is examined from Xray.
Fracture healing
Fracture healing is examined from Xray.

Full Information

First Posted
September 10, 2010
Last Updated
September 10, 2010
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01199653
Brief Title
Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures
Official Title
Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle, Fracture
Keywords
clavicle fractures, midshaft, dislocated, operative treatment, conservative treatment, non-operative treatment, randomized controlled trial, bone plates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-operative treatment
Arm Type
Active Comparator
Arm Description
Non-operative (conservative) treatment of the clavicle fracture
Arm Title
Operative treatment
Arm Type
Active Comparator
Arm Description
Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.
Intervention Type
Procedure
Intervention Name(s)
Operative treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Non-operative treatment with arm immobilised to a sling
Intervention Description
Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Primary Outcome Measure Information:
Title
Shoulder function
Description
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.
Time Frame
Three months
Title
Shoulder function
Description
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.
Time Frame
One year
Title
Shoulder function
Description
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.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
Three months
Title
Pain at rest and activity
Description
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.
Time Frame
Three weeks
Title
Fracture healing
Description
Fracture healing is examined from Xray.
Time Frame
Three months
Title
Complications
Description
Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.
Time Frame
Continous till two years
Title
Disability of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
One year
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
Two years
Title
Pain at rest and activity
Description
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.
Time Frame
Six weeks
Title
Pain at rest and at activity
Description
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
Time Frame
Three months
Title
Pain at rest and at activity
Description
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
Time Frame
One year
Title
Pain at rest and at activity
Description
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
Time Frame
Two years
Title
Fracture healing
Description
Fracture healing is examined from Xray.
Time Frame
One year
Title
Fracture healing
Description
Fracture healing is examined from Xray.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaisa J Virtanen, MD
Organizational Affiliation
Helsinki Uiversity Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ville Remes, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jarkko Pajarinen, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vesa Savolainen, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan-Magnus Björkenheim, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mika P Paavola, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Central Hospital, Töölö Hospital
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00260
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17200303
Citation
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.
Results Reference
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PubMed Identifier
9250733
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. doi: 10.1302/0301-620x.79b4.7529.
Results Reference
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PubMed Identifier
8745801
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. doi: 10.1016/0020-1383(95)00148-4.
Results Reference
background
PubMed Identifier
14426324
Citation
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.
Results Reference
background
PubMed Identifier
8131324
Citation
Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32.
Results Reference
background
PubMed Identifier
15383801
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. doi: 10.1016/j.jse.2004.01.026.
Results Reference
background
PubMed Identifier
10775691
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. doi: 10.1016/s0020-1383(99)00312-5.
Results Reference
background
PubMed Identifier
1618563
Citation
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.
Results Reference
background
PubMed Identifier
16056089
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. doi: 10.1097/01.bot.0000172287.44278.ef.
Results Reference
background

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Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

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