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Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

This study has been completed.
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01199653
First received: September 10, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

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 November 20, 2014