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Cast Immobilization for Non-Displaced Scaphoid Fractures

Primary Purpose

Non-displaced Scaphoid Fractures

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cast that immobilizes the thumb

Cast that does not immobilize the thumb

About this trial

This is an interventional treatment trial for Non-displaced Scaphoid Fractures

Eligibility Criteria

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

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

Sites / Locations

Massachusettes General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cast that immobilizes the thumb

Cast that does not immobilize the thumb

Arm Description

Cast that immobilizes the thumb

Cast that does not immobilize the thumb

Outcomes

Primary Outcome Measures

Extent of Union

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

Secondary Outcome Measures

DASH Questionnaire

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

Modified Mayo Wrist Score

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.

Grip Strength

Visual Analog Scale for Pain

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.

Range of Motion: Flexion

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

Range of Motion: Extension

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

Range of Motion: Ulnar Deviation

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

Range of Motion: Radial Deviation

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

Full Information

NCT ID

NCT00916539

First Posted

June 5, 2009

Last Updated

March 1, 2017

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00916539

Brief Title

Cast Immobilization for Non-Displaced Scaphoid Fractures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-displaced Scaphoid Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cast that immobilizes the thumb

Arm Type

Experimental

Arm Description

Cast that immobilizes the thumb

Arm Title

Cast that does not immobilize the thumb

Arm Type

Active Comparator

Arm Description

Cast that does not immobilize the thumb

Intervention Type

Device

Intervention Name(s)

Cast that immobilizes the thumb

Intervention Description

Cast that immobilizes the thumb

Intervention Type

Device

Intervention Name(s)

Cast that does not immobilize the thumb

Intervention Description

Cast that does not immobilize the thumb

Primary Outcome Measure Information:

Title

Extent of Union

Description

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

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

DASH Questionnaire

Description

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

Time Frame

6 months

Title

Modified Mayo Wrist Score

Description

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.

Time Frame

6 months

Title

Grip Strength

Time Frame

6 months

Title

Visual Analog Scale for Pain

Description

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.

Time Frame

6 months

Title

Range of Motion: Flexion

Description

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

Time Frame

6 months

Title

Range of Motion: Extension

Description

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

Time Frame

6 months

Title

Range of Motion: Ulnar Deviation

Description

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

Time Frame

6 months

Title

Range of Motion: Radial Deviation

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David C Ring, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusettes General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Cast Immobilization for Non-Displaced Scaphoid Fractures

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