Trial Outcomes & Findings for Active Versus Passive Motion Device Following Knee Replacement Surgery (NCT NCT02339831)
NCT ID: NCT02339831
Last Updated: 2017-03-20
Results Overview
Quadriceps strength measurements using a hand held dynamometer
COMPLETED
NA
110 participants
4-6 weeks post-op
2017-03-20
Participant Flow
1153 patients electing to undergo unilateral partial or total knee replacement at the New England Baptist Hospital from 03/2007-12/2010 were screened for participation. Of these patients, 110 elected to participate in the study and were randomized into one of the two study groups.
Participant milestones
| Measure |
Active Motion Device
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
52
|
|
Overall Study
Lost to Follow Up
|
20
|
7
|
|
Overall Study
COMPLETED
|
38
|
45
|
|
Overall Study
NOT COMPLETED
|
20
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Active Versus Passive Motion Device Following Knee Replacement Surgery
Baseline characteristics by cohort
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
64.7 years
STANDARD_DEVIATION 9.2 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Kinesthesia
|
3.20 degrees
STANDARD_DEVIATION 2.64 • n=99 Participants
|
4.24 degrees
STANDARD_DEVIATION 3.34 • n=107 Participants
|
3.7 degrees
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
Quadriceps Strength
|
12.4 newton meter
STANDARD_DEVIATION 4.7 • n=99 Participants
|
11.2 newton meter
STANDARD_DEVIATION 4.7 • n=107 Participants
|
11.8 newton meter
STANDARD_DEVIATION 4.7 • n=206 Participants
|
|
Balance
|
3.61 units on a scale
STANDARD_DEVIATION 1.69 • n=99 Participants
|
3.62 units on a scale
STANDARD_DEVIATION 1.39 • n=107 Participants
|
3.62 units on a scale
STANDARD_DEVIATION 1.53 • n=206 Participants
|
|
Knee Flexion
|
113.8 degrees
STANDARD_DEVIATION 12.8 • n=99 Participants
|
111.6 degrees
STANDARD_DEVIATION 12.8 • n=107 Participants
|
112.6 degrees
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
SF-36 Mental Health Score
|
43.4 units on a scale
STANDARD_DEVIATION 7.5 • n=99 Participants
|
43.2 units on a scale
STANDARD_DEVIATION 8.1 • n=107 Participants
|
43.3 units on a scale
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Knee Society Score
|
56.0 units on a scale
STANDARD_DEVIATION 13.7 • n=99 Participants
|
49.3 units on a scale
STANDARD_DEVIATION 14.9 • n=107 Participants
|
54.7 units on a scale
STANDARD_DEVIATION 17.8 • n=206 Participants
|
|
WOMAC
|
64.1 units on a scale
STANDARD_DEVIATION 14.9 • n=99 Participants
|
67.1 units on a scale
STANDARD_DEVIATION 20.3 • n=107 Participants
|
65.7 units on a scale
STANDARD_DEVIATION 17.7 • n=206 Participants
|
|
Sit-to-Stand Test
|
3.37 seconds
STANDARD_DEVIATION 1.18 • n=99 Participants
|
3.40 seconds
STANDARD_DEVIATION 1.48 • n=107 Participants
|
3.39 seconds
STANDARD_DEVIATION 1.34 • n=206 Participants
|
|
SF-36 Physical Health Score
|
35.1 units on a scale
STANDARD_DEVIATION 6.3 • n=99 Participants
|
35.0 units on a scale
STANDARD_DEVIATION 6.8 • n=107 Participants
|
35.0 units on a scale
STANDARD_DEVIATION 6.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks post-opQuadriceps strength measurements using a hand held dynamometer
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
Early Functional Outcome Strength
|
12.02 newton meter
Standard Deviation 4.12
|
11.60 newton meter
Standard Deviation 4.34
|
PRIMARY outcome
Timeframe: 4-6 weeks post-opSit-to-Stand test: After one demonstration of the sit-to-stand test, standing up from a seated position without support, two tests were timed and the better value recorded. Patient was asked to sit with back against chair and told to stand up without using any support. Arms were suggested to be folded in front of chest. Time started with recorded said "Go".
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
Early Functional Outcome by Sit to Stand Test
|
2.83 seconds
Standard Deviation .98
|
3.43 seconds
Standard Deviation 1.23
|
PRIMARY outcome
Timeframe: 4-6 weeks post-opBiodex Balance Machine Score. The system consists of a multiaxial standing platform with a maximum tilt of 20 degrees. All participants were tested on level 8, and a balance index was calculated using the time and deviation (in degrees) on the platform relative to a neutral position. The normal range for adults 54-71 is 1.79 - 3.35. Lower values indicate better/greater stability.
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
Early Functional Outcome Proprioception
|
3.11 units on a scale
Standard Deviation 1.56
|
2.98 units on a scale
Standard Deviation 1.27
|
PRIMARY outcome
Timeframe: 4-6 weeks post opKinesthesia was measured by recording the angle of the flexed knee and documenting how close the patient was able to reproduce the angle with closed eyes. The differences were recorded in degrees using an 8-inch goniometer.
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
Early Function Outcome Kinesthesia
|
2.90 degress
Standard Deviation 2.99
|
2.98 degress
Standard Deviation 2.32
|
PRIMARY outcome
Timeframe: 4-6 weeks post opKnee-flexion was measured using an 8-inch goniometer.
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
Early Functional Outcome Knee Flexion
|
104.3 degrees
Standard Deviation 15.0
|
101.0 degrees
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 4-6 weeks post-opShort form 36 mental health score. The scale is measured from 0-100. 0 is the lowest or worst possible level of functioning and 100 is the highest or best possible level of functioning.
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
General Mental Orthopaedic Outcome Measures
|
40.2 units on a scale
Standard Deviation 8.8
|
39.4 units on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 4-6 weeks post-opWestern Ontario and McMaster Universities Arthritis Index is measured on a scale of 0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
General Activity Orthopaedic Outcome Measures
|
45.8 units on a scale
Standard Deviation 13.6
|
50.2 units on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 4-6 weeks post-opKnee society score is an objective patient reported outcome survey to measure a patient's functional ability before and after knee arthroplasty. It is measured on a scale of 1-100. A score between 80-100 indicated excellent functioning, a score between 70-79 indicates good functioning, a score between 60-69 indicates fair functioning, and a score below 60 indicates poor functioning.
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
General Functional Orthopaedic Outcome Measures
|
64.7 units on a scale
Standard Deviation 17.0
|
62.6 units on a scale
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: 4-6 weeks post-opSelf-reported total pain medication consumption was recorded by patients and at the end of the four-week period converted into standard units for comparison as "oxycodone equivalent dosage".
Outcome measures
| Measure |
Active Motion Device
n=38 Participants
Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
|
Passive Motion Device
n=45 Participants
Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
|
|---|---|---|
|
General Pain
|
471.77 mg
Standard Deviation 457.46
|
346.97 mg
Standard Deviation 289.85
|
Adverse Events
Active Motion Device
Passive Motion Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place