Trial Outcomes & Findings for Cast Immobilization for Non-Displaced Scaphoid Fractures (NCT NCT00916539)

NCT ID: NCT00916539

Last Updated: 2017-04-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2017-04-12

Participant Flow

Participant milestones

Measure	Cast That Immobilizes the Thumb Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb Cast that does not immobilize the thumb
Overall Study STARTED	31	31
Overall Study COMPLETED	31	31
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cast Immobilization for Non-Displaced Scaphoid Fractures

Baseline characteristics by cohort

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb	Total n=62 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 14 • n=93 Participants	42 years STANDARD_DEVIATION 18 • n=4 Participants	37.5 years STANDARD_DEVIATION 17.0 • n=27 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	21 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment United States	31 participants n=93 Participants	31 participants n=4 Participants	62 participants n=27 Participants

PRIMARY outcome

Timeframe: 10 weeks

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

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Extent of Union	70 percentage of union Standard Deviation 30	85 percentage of union Standard Deviation 24

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
DASH Questionnaire	5 units on a scale Standard Deviation 8	6 units on a scale Standard Deviation 9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Modified Mayo Wrist Score	92 units on a scale Standard Deviation 9	87 units on a scale Standard Deviation 19

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Grip Strength	40 kilograms Standard Deviation 21	37 kilograms Standard Deviation 21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Visual Analog Scale for Pain	1.1 units on a scale Standard Deviation 1.4	0.8 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Range of Motion: Flexion	76 degrees Standard Deviation 12	72 degrees Standard Deviation 9

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Range of Motion: Extension	68 degrees Standard Deviation 15	67 degrees Standard Deviation 14

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Range of Motion: Ulnar Deviation	38 degrees Standard Deviation 13	32 degrees Standard Deviation 8

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Cast That Immobilizes the Thumb n=31 Participants Cast that immobilizes the thumb	Cast That Does Not Immobilize the Thumb n=31 Participants Cast that does not immobilize the thumb
Range of Motion: Radial Deviation	20 degrees Standard Deviation 9	19 degrees Standard Deviation 7

Adverse Events

Cast That Immobilizes the Thumb

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cast That Does Not Immobilize the Thumb

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Taylor Pong, Research Coordinator

Massachusetts General Hospital

Phone: 617-726-1569

Email: tpong1@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place