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Completed

NCT Number: NCT00916539

Cast Immobilization for Non-Displaced Scaphoid Fractures

This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.

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Key information

Conditions

Non-displaced Scaphoid Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusettes General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Isolated fracture of the scaphoid
  • No displacement of the scaphoid fracture on CT scan

Exclusion criteria

  • Associated ipsilateral ligament injury or fracture
  • Pregnant Patient

Treatment and study plan

Cast that immobilizes the thumb

Device

Cast that immobilizes the thumb

Cast that does not immobilize the thumb

Device

Cast that does not immobilize the thumb

Primary outcomes

  1. Extent of Union

    Time frame: 10 weeks

    The investigators looked at the extent of fracture union after immobilization.

Secondary outcomes

  1. DASH Questionnaire

    Time frame: 6 months

    This questionnaire measures the disability of the upper extremity. The disability scale is ranked from 0 (least disability) to 100 (most disability).

  2. Modified Mayo Wrist Score

    Time frame: 6 months

    The Modified Mayo Wrist Score evaluates wrist function after treatment. The total score ranges from 0 to 100, with higher scores indicating a better result.

  3. Grip Strength

    Time frame: 6 months

  4. Visual Analog Scale for Pain

    Time frame: 6 months

    The pain scale measures the amount of pain on a scale from 0 to 10, where 10 indicates the most pain and 0 is no pain.

  5. Range of Motion: Flexion

    Time frame: 6 months

    Range of motion measures the ability to move the wrist joint after injury.

  6. Range of Motion: Extension

    Time frame: 6 months

    Range of motion measures the ability to move the wrist joint after injury.

  7. Range of Motion: Ulnar Deviation

    Time frame: 6 months

    Range of motion measures the ability to move the wrist joint after injury.

  8. Range of Motion: Radial Deviation

    Time frame: 6 months

    Range of motion measures the ability to move the wrist joint after injury.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Jun 9, 2009
Registry last updated
Apr 12, 2017

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.