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Completed

NCT Number: NCT01199653

Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

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

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Key information

Conditions

Clavicle Fracture Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Helsinki University Central Hospital, Töölö Hospital

Helsinki, Uusimaa, 00260, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operative treatment

Procedure

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

Procedure

Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.

Primary outcomes

  1. Shoulder function

    Time frame: Three months

    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.

  2. Shoulder function

    Time frame: One year

    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.

  3. Shoulder function

    Time frame: Two years

    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 outcomes

  1. Disability of the Arm, Shoulder and Hand (DASH)

    Time frame: Three months

    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.

  2. Pain at rest and activity

    Time frame: Three weeks

    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.

  3. Fracture healing

    Time frame: Three months

    Fracture healing is examined from Xray.

  4. Complications

    Time frame: Continous till two years

    Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.

  5. Disability of the Arm, Shoulder and Hand (DASH)

    Time frame: One year

    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.

  6. Disabilities of the Arm, Shoulder and Hand (DASH)

    Time frame: Two years

    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.

  7. Pain at rest and activity

    Time frame: Six weeks

    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.

  8. Pain at rest and at activity

    Time frame: Three months

    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

  9. Pain at rest and at activity

    Time frame: One year

    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

  10. Pain at rest and at activity

    Time frame: Two years

    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

  11. Fracture healing

    Time frame: One year

    Fracture healing is examined from Xray.

  12. Fracture healing

    Time frame: Two years

    Fracture healing is examined from Xray.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Sep 13, 2010
Registry last updated
Sep 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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