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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

4-6 weeks post-op

Results posted on

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

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

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-op

Quadriceps strength measurements using a hand held dynamometer

Outcome measures

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-op

Sit-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

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-op

Biodex 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

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 op

Kinesthesia 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

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 op

Knee-flexion was measured using an 8-inch goniometer.

Outcome measures

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-op

Short 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

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-op

Western 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

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-op

Knee 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

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-op

Self-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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Passive Motion Device

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

Wolfgang Fitz MD

Brigham and Women's Hospital

Phone: 617-732-9500

Results disclosure agreements

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