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

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ClinicalTrials.gov Identifier: NCT03312933
Recruitment Status : Completed
First Posted : October 18, 2017
Results First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Jeremy Smith, Brigham and Women's Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Pain
Ankle Injuries
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CAM Walker Boot for >2 Weeks
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 100
Completed 46
Not Completed 54
Reason Not Completed
Protocol Violation             15
Lost to Follow-up             36
Withdrawal by Subject             3
Arm/Group Title CAM Walker Boot for >2 Weeks
Hide Arm/Group Description 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 Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
49
(22 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
15
  32.6%
Male
31
  67.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Hispanic or Latino
2
   4.3%
Not Hispanic or Latino
42
  91.3%
Unknown or Not Reported
2
   4.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.3%
White
39
  84.8%
More than one race
0
   0.0%
Unknown or Not Reported
4
   8.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
Body Mass Index   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Normal (below 25) 24
Overweight (25-30) 10
Obese (above 30) 12
[1]
Measure Description: A BMI was calculated for each patient. The were then separated into Normal (below 25 kg/m^2), Overweight (25-30 kg/m^2), and Obese (above 30 kg/m^2).
Injury Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Fracture
17
  37.0%
Sprain
7
  15.2%
Tendon Problem
17
  37.0%
Other
5
  10.9%
Secondary Site Pain  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
One or more secondary site pains
27
  58.7%
No secondary site pains
19
  41.3%
Type of CAM walker boot  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Tall CAM Boot
31
  67.4%
Short CAM Boot
15
  32.6%
1.Primary Outcome
Title The Presence and Severity of Secondary Site Pain
Hide Description 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.
Time Frame At the time of transitioning out of the boot
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duration of CAM Walking Boot Wear >2 Weeks
Hide Arm/Group Description:
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 Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
31
  67.4%
Time Frame Patients were followed until three months after transitioning out of the boot.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CAM Walker Boot for >2 Weeks
Hide Arm/Group Description 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.
All-Cause Mortality
CAM Walker Boot for >2 Weeks
Affected / at Risk (%)
Total   0/46 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CAM Walker Boot for >2 Weeks
Affected / at Risk (%)
Total   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CAM Walker Boot for >2 Weeks
Affected / at Risk (%)
Total   0/46 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeremy T. Smith
Organization: Brigham and Women's Hospital
Phone: (617) 983-7295
EMail: jsmith42@bwh.harvard.edu
Layout table for additonal information
Responsible Party: Jeremy Smith, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03312933     History of Changes
Other Study ID Numbers: 2015P000327/BWH
First Submitted: October 13, 2017
First Posted: October 18, 2017
Results First Submitted: October 26, 2017
Results First Posted: January 18, 2019
Last Update Posted: January 18, 2019