Trial Outcomes & Findings for Associated Joint Pain With Controlled Ankle Movement (CAM) Walker Boot Wear (NCT NCT03312933)

Last Updated: 2019-01-18

Results Overview

The primary outcome was the presence of secondary site pain that developed or worsened during CAM walker boot wear. Surveys inquired about the presence of secondary site pain, defined as lower back, ipsilateral hip, contralateral hip, ipsilateral knee, contralateral knee, contralateral ankle, and contralateral foot. Severity of pain was assessed using a 100-point visual analog scale (VAS), with zero indicating no pain and 100 representing the worst pain imaginable.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

At the time of transitioning out of the boot

Results posted on

2019-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	CAM Walker Boot for >2 Weeks All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
Overall Study STARTED	100
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Reasons for withdrawal
Measure	CAM Walker Boot for >2 Weeks All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
Overall Study Protocol Violation	15
Overall Study Lost to Follow-up	36
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Associated Joint Pain With Controlled Ankle Movement (CAM) Walker Boot Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAM Walker Boot for >2 Weeks n=46 Participants All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants
Body Mass Index Normal (below 25)	24 participants n=5 Participants
Body Mass Index Overweight (25-30)	10 participants n=5 Participants
Body Mass Index Obese (above 30)	12 participants n=5 Participants
Injury Type Fracture	17 Participants n=5 Participants
Injury Type Sprain	7 Participants n=5 Participants
Injury Type Tendon Problem	17 Participants n=5 Participants
Injury Type Other	5 Participants n=5 Participants
Secondary Site Pain One or more secondary site pains	27 Participants n=5 Participants
Secondary Site Pain No secondary site pains	19 Participants n=5 Participants
Type of CAM walker boot Tall CAM Boot	31 Participants n=5 Participants
Type of CAM walker boot Short CAM Boot	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of transitioning out of the boot

Outcome measures

Outcome measures
Measure	Duration of CAM Walking Boot Wear >2 Weeks n=46 Participants All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study.
The Presence and Severity of Secondary Site Pain	31 Participants

Adverse Events

CAM Walker Boot for >2 Weeks

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

Dr. Jeremy T. Smith

Brigham and Women's Hospital

Phone: (617) 983-7295

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place