Trial Outcomes & Findings for Home Rehabilitation in Patients After Primary Total Knee Arthroplasty (NCT NCT02409719)
NCT ID: NCT02409719
Last Updated: 2019-12-19
Results Overview
The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC). It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. * Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96. * For each subscale higher values represent worse outcomes. * Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities.
COMPLETED
NA
76 participants
up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)
2019-12-19
Participant Flow
Recruitment was held in the outpatient clinic in the area of Orthopedics and Traumatology of the investigators hospital with a diagnosis of knee osteoarthritis, which treatment requires surgery in which the recruitment process started June 2014 until January 2019. The objective was to recruit 76 patients were randomly divided into two groups.
6 patients were lost to follow up.
Participant milestones
| Measure |
Control - Verbal Information and Booklet
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
45
|
|
Overall Study
2 Weeks
|
28
|
42
|
|
Overall Study
4 Weeks
|
28
|
42
|
|
Overall Study
6 Weeks
|
28
|
42
|
|
Overall Study
3 Months
|
28
|
42
|
|
Overall Study
6 Months
|
28
|
42
|
|
Overall Study
12 Months
|
28
|
42
|
|
Overall Study
COMPLETED
|
28
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Control - Verbal Information and Booklet
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control - Verbal Information and Booklet
n=28 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
n=42 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=70 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=28 Participants
|
14 Participants
n=42 Participants
|
22 Participants
n=70 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=28 Participants
|
28 Participants
n=42 Participants
|
48 Participants
n=70 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=28 Participants
|
22 Participants
n=42 Participants
|
34 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=28 Participants
|
20 Participants
n=42 Participants
|
36 Participants
n=70 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Knee right or left
Right Knee
|
14 participants
n=28 Participants
|
24 participants
n=42 Participants
|
38 participants
n=70 Participants
|
|
Knee right or left
Left Knee
|
14 participants
n=28 Participants
|
18 participants
n=42 Participants
|
32 participants
n=70 Participants
|
PRIMARY outcome
Timeframe: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC). It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints. * Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96. * For each subscale higher values represent worse outcomes. * Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities.
Outcome measures
| Measure |
Control - Verbal Information and Booklet
n=28 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
n=42 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
|---|---|---|
|
Total WOMAC Score
0 weeks
|
51.64285714 score on a scale
Standard Deviation 17.26957137
|
52.47619048 score on a scale
Standard Deviation 20.96947619
|
|
Total WOMAC Score
2 weeks
|
39.60714286 score on a scale
Standard Deviation 18.01920639
|
40.38095238 score on a scale
Standard Deviation 16.73458866
|
|
Total WOMAC Score
4 weeks
|
29.42857143 score on a scale
Standard Deviation 13.48916869
|
30.85714286 score on a scale
Standard Deviation 14.35197178
|
|
Total WOMAC Score
6 weeks
|
25.32142857 score on a scale
Standard Deviation 16.60444735
|
24.88095238 score on a scale
Standard Deviation 14.11140756
|
|
Total WOMAC Score
3 months
|
16 score on a scale
Standard Deviation 11.18861856
|
20.19047619 score on a scale
Standard Deviation 11.89842805
|
|
Total WOMAC Score
6 months
|
10.28571429 score on a scale
Standard Deviation 7.721337165
|
14.11904762 score on a scale
Standard Deviation 8.969330891
|
|
Total WOMAC Score
12 months
|
6.571428571 score on a scale
Standard Deviation 6.941173833
|
9.166666667 score on a scale
Standard Deviation 7.525296094
|
SECONDARY outcome
Timeframe: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain " (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (scale of 10).
Outcome measures
| Measure |
Control - Verbal Information and Booklet
n=28 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
n=42 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
|---|---|---|
|
Visual Analog Scale (Measure of Pain Intensity)
12 months
|
0.678571429 score on a scale
Standard Deviation 0.944911183
|
0.761904762 score on a scale
Standard Deviation 1.225929688
|
|
Visual Analog Scale (Measure of Pain Intensity)
0 weeks
|
8.178571429 score on a scale
Standard Deviation 1.906199854
|
8.285714286 score on a scale
Standard Deviation 1.8251056
|
|
Visual Analog Scale (Measure of Pain Intensity)
2 weeks
|
5.392857143 score on a scale
Standard Deviation 2.114137346
|
5.714285714 score on a scale
Standard Deviation 2.051599189
|
|
Visual Analog Scale (Measure of Pain Intensity)
4 weeks
|
4 score on a scale
Standard Deviation 1.943650632
|
4.261904762 score on a scale
Standard Deviation 2.012879551
|
|
Visual Analog Scale (Measure of Pain Intensity)
6 weeks
|
3 score on a scale
Standard Deviation 2.388242807
|
3.333333333 score on a scale
Standard Deviation 2.385593618
|
|
Visual Analog Scale (Measure of Pain Intensity)
3 months
|
2.214285714 score on a scale
Standard Deviation 2.266619981
|
2.619047619 score on a scale
Standard Deviation 2.197031045
|
|
Visual Analog Scale (Measure of Pain Intensity)
6 months
|
1.428571429 score on a scale
Standard Deviation 1.687175405
|
1.785714286 score on a scale
Standard Deviation 1.746574547
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)The Oxford Knee Score is a 12-item patient-reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes. Consists of 12 multiple choice questions consisting of five answers with a maximum score of 60. Score ranges * Score 0 to 19: May indicate severe knee arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon. * Score 20 to 29: May indicate moderate to severe knee arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon. * Score 30 to 39: May indicate mild to moderate knee arthritis. Consider seeing your family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory med
Outcome measures
| Measure |
Control - Verbal Information and Booklet
n=28 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
n=42 Participants
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
|---|---|---|
|
Oxford Knee Score (OKS)
0 weeks
|
17.10714286 units on a scale
Standard Deviation 6.436811298
|
17.45238095 units on a scale
Standard Deviation 8.554566263
|
|
Oxford Knee Score (OKS)
2 weeks
|
22.60714286 units on a scale
Standard Deviation 7.568645291
|
21.35714286 units on a scale
Standard Deviation 7.367765749
|
|
Oxford Knee Score (OKS)
4 weeks
|
28.5 units on a scale
Standard Deviation 5.666666667
|
25.90243902 units on a scale
Standard Deviation 7.059762312
|
|
Oxford Knee Score (OKS)
6 weeks
|
32 units on a scale
Standard Deviation 7.693190832
|
30.02380952 units on a scale
Standard Deviation 7.202601479
|
|
Oxford Knee Score (OKS)
3 months
|
36.89285714 units on a scale
Standard Deviation 6.020577588
|
33.54761905 units on a scale
Standard Deviation 6.868813868
|
|
Oxford Knee Score (OKS)
6 months
|
38.78571429 units on a scale
Standard Deviation 7.067699835
|
37.42857143 units on a scale
Standard Deviation 5.926965485
|
|
Oxford Knee Score (OKS)
12 months
|
41.21428571 units on a scale
Standard Deviation 5.902649392
|
40.54761905 units on a scale
Standard Deviation 4.357233296
|
Adverse Events
Control - Verbal Information and Booklet
Study - Verbal Information, Booklet & Schedule.
Serious adverse events
| Measure |
Control - Verbal Information and Booklet
n=28 participants at risk
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given.
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
Study - Verbal Information, Booklet & Schedule.
n=42 participants at risk
Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
Schedule: Illustrative daily planner to point the day that the exercise was performed
Verbal Information and Booklet: Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hospitalization
|
0.00%
0/28 • up to 12 months
|
2.4%
1/42 • Number of events 1 • up to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place