Trial Outcomes & Findings for Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis (NCT NCT01746420)
NCT ID: NCT01746420
Last Updated: 2019-07-02
Results Overview
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline, 2, 4, 8, 12, and 24 weeks
Results posted on
2019-07-02
Participant Flow
Participant milestones
| Measure |
Placebo Control
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
17
|
18
|
17
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
3
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Baseline characteristics by cohort
| Measure |
Placebo Control
n=20 Participants
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
n=20 Participants
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 Participants
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 Participants
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 Participants
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age
|
44.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
49 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
46 years
STANDARD_DEVIATION 7 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 12.4 • n=4 Participants
|
49 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
47.1 years
STANDARD_DEVIATION 8.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
51 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
49 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
89 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, 8, 12, and 24 weeksPopulation: Analysis conducted on patients at Baseline, 2, 4, 8, 12, and 24 weeks time points.
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Outcome measures
| Measure |
Placebo Control
n=20 Participants
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
n=20 Participants
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 Participants
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 Participants
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 Participants
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Elbow Pain Assessments (VAS), Treated Subjects
Week 24
|
16.9 score on a scale
Standard Deviation 21
|
23.1 score on a scale
Standard Deviation 25.6
|
28.5 score on a scale
Standard Deviation 26
|
23.8 score on a scale
Standard Deviation 28.2
|
32.1 score on a scale
Standard Deviation 31.4
|
|
Elbow Pain Assessments (VAS), Treated Subjects
Baseline
|
76.6 score on a scale
Standard Deviation 14.4
|
77.7 score on a scale
Standard Deviation 9.2
|
75.9 score on a scale
Standard Deviation 16.9
|
72 score on a scale
Standard Deviation 19.9
|
72.2 score on a scale
Standard Deviation 20.6
|
|
Elbow Pain Assessments (VAS), Treated Subjects
Week 2
|
67.1 score on a scale
Standard Deviation 15
|
73.2 score on a scale
Standard Deviation 14.6
|
78.5 score on a scale
Standard Deviation 18.4
|
59.7 score on a scale
Standard Deviation 22.7
|
70 score on a scale
Standard Deviation 26.6
|
|
Elbow Pain Assessments (VAS), Treated Subjects
Week 4
|
49.9 score on a scale
Standard Deviation 18
|
49.8 score on a scale
Standard Deviation 21.1
|
55.5 score on a scale
Standard Deviation 27
|
40.2 score on a scale
Standard Deviation 24.1
|
52.5 score on a scale
Standard Deviation 27.3
|
|
Elbow Pain Assessments (VAS), Treated Subjects
Week 8
|
35.9 score on a scale
Standard Deviation 23.4
|
39.7 score on a scale
Standard Deviation 19.5
|
47.2 score on a scale
Standard Deviation 20.8
|
33 score on a scale
Standard Deviation 27.2
|
39.1 score on a scale
Standard Deviation 28.8
|
|
Elbow Pain Assessments (VAS), Treated Subjects
Week 12
|
28.7 score on a scale
Standard Deviation 20.2
|
31.2 score on a scale
Standard Deviation 21.6
|
36.7 score on a scale
Standard Deviation 25.3
|
29.8 score on a scale
Standard Deviation 29.7
|
40.4 score on a scale
Standard Deviation 29
|
PRIMARY outcome
Timeframe: Baseline, 4, 8, 12, and 24 weeksPopulation: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
Outcome measures
| Measure |
Placebo Control
n=20 Participants
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
n=20 Participants
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 Participants
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 Participants
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 Participants
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
Baseline
|
43.7 score on a scale
Standard Deviation 13.9
|
43.5 score on a scale
Standard Deviation 13.5
|
40.1 score on a scale
Standard Deviation 19.8
|
40 score on a scale
Standard Deviation 15.3
|
41.3 score on a scale
Standard Deviation 18.5
|
|
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
Week 4
|
29.2 score on a scale
Standard Deviation 12.5
|
30.9 score on a scale
Standard Deviation 12.8
|
34.1 score on a scale
Standard Deviation 18.3
|
27.8 score on a scale
Standard Deviation 20.2
|
38.3 score on a scale
Standard Deviation 22.9
|
|
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
Week 8
|
21.8 score on a scale
Standard Deviation 11.5
|
23 score on a scale
Standard Deviation 14.2
|
24.7 score on a scale
Standard Deviation 14.9
|
19.7 score on a scale
Standard Deviation 16.4
|
25.1 score on a scale
Standard Deviation 22.5
|
|
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
Week 12
|
12.6 score on a scale
Standard Deviation 8.6
|
16.7 score on a scale
Standard Deviation 13.2
|
19.8 score on a scale
Standard Deviation 15.3
|
16.1 score on a scale
Standard Deviation 15.9
|
24.5 score on a scale
Standard Deviation 23.7
|
|
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
Week 24
|
7.2 score on a scale
Standard Deviation 9.6
|
11.4 score on a scale
Standard Deviation 9.9
|
14.5 score on a scale
Standard Deviation 17.3
|
13.8 score on a scale
Standard Deviation 15.6
|
19.6 score on a scale
Standard Deviation 24.3
|
PRIMARY outcome
Timeframe: Baseline, 4, 8, 12, and 24 weeksPopulation: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) -Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) * Specific activities - 6 items * Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally
Outcome measures
| Measure |
Placebo Control
n=20 Participants
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
n=20 Participants
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 Participants
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 Participants
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 Participants
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
Baseline
|
52.6 score on a scale
Standard Deviation 17.9
|
56 score on a scale
Standard Deviation 14.3
|
48.3 score on a scale
Standard Deviation 16.3
|
52.6 score on a scale
Standard Deviation 20.7
|
52.3 score on a scale
Standard Deviation 22.9
|
|
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
Week 4
|
34.7 score on a scale
Standard Deviation 14.5
|
39.2 score on a scale
Standard Deviation 15.3
|
39.3 score on a scale
Standard Deviation 21.7
|
32.2 score on a scale
Standard Deviation 23.9
|
43.4 score on a scale
Standard Deviation 24.3
|
|
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
Week 8
|
25.2 score on a scale
Standard Deviation 15.2
|
26.9 score on a scale
Standard Deviation 17.4
|
28.9 score on a scale
Standard Deviation 15.1
|
25.4 score on a scale
Standard Deviation 21
|
28.6 score on a scale
Standard Deviation 24.9
|
|
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
Week 12
|
13.5 score on a scale
Standard Deviation 8
|
18.2 score on a scale
Standard Deviation 16.4
|
22.3 score on a scale
Standard Deviation 16.4
|
20.1 score on a scale
Standard Deviation 22.7
|
26.8 score on a scale
Standard Deviation 24.8
|
|
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
Week 24
|
7.8 score on a scale
Standard Deviation 10
|
12.1 score on a scale
Standard Deviation 12.4
|
16.2 score on a scale
Standard Deviation 17.9
|
16.8 score on a scale
Standard Deviation 19.3
|
22.3 score on a scale
Standard Deviation 27.3
|
PRIMARY outcome
Timeframe: Baseline, 4, 8, 12, and 24 weeksPopulation: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.
Outcome measures
| Measure |
Placebo Control
n=20 Participants
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
n=20 Participants
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 Participants
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 Participants
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 Participants
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Grip Strength Test, All Treated Subjects
Baseline
|
42.6 lbs.
Standard Deviation 30.1
|
33.4 lbs.
Standard Deviation 24.1
|
47.6 lbs.
Standard Deviation 29.4
|
39.6 lbs.
Standard Deviation 28.9
|
39.7 lbs.
Standard Deviation 23.2
|
|
Grip Strength Test, All Treated Subjects
Week 4
|
40.2 lbs.
Standard Deviation 25.6
|
44.5 lbs.
Standard Deviation 32
|
48.3 lbs.
Standard Deviation 33
|
52 lbs.
Standard Deviation 30.2
|
41.9 lbs.
Standard Deviation 26.3
|
|
Grip Strength Test, All Treated Subjects
Week 8
|
53.5 lbs.
Standard Deviation 27.8
|
50.6 lbs.
Standard Deviation 36.3
|
64.6 lbs.
Standard Deviation 35
|
53.3 lbs.
Standard Deviation 29
|
54.8 lbs.
Standard Deviation 26.4
|
|
Grip Strength Test, All Treated Subjects
Week 12
|
58.2 lbs.
Standard Deviation 28.1
|
61 lbs.
Standard Deviation 37.7
|
67.5 lbs.
Standard Deviation 38.3
|
61.1 lbs.
Standard Deviation 32.1
|
45.1 lbs.
Standard Deviation 25.3
|
|
Grip Strength Test, All Treated Subjects
Week 24
|
66.4 lbs.
Standard Deviation 26.4
|
69.1 lbs.
Standard Deviation 37.5
|
79.9 lbs.
Standard Deviation 33.4
|
69.9 lbs.
Standard Deviation 29.1
|
62.9 lbs.
Standard Deviation 25.7
|
PRIMARY outcome
Timeframe: Baseline, 4, 8, 12, and 24 weeksPopulation: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.
A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.
Outcome measures
| Measure |
Placebo Control
n=20 Participants
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.45 mg rhPDGF-BB
n=20 Participants
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 Participants
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 Participants
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 Participants
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Maximum Grip Strength, Treated Subjects
Baseline
|
60.4 lbs.
Standard Deviation 35
|
58.7 lbs.
Standard Deviation 33.1
|
71.8 lbs.
Standard Deviation 38.9
|
60.3 lbs.
Standard Deviation 31.2
|
61.3 lbs.
Standard Deviation 29.7
|
|
Maximum Grip Strength, Treated Subjects
Week 4
|
62.9 lbs.
Standard Deviation 26.2
|
63.5 lbs.
Standard Deviation 33.1
|
64.2 lbs.
Standard Deviation 37.2
|
68.9 lbs.
Standard Deviation 35.5
|
62 lbs.
Standard Deviation 33
|
|
Maximum Grip Strength, Treated Subjects
Week 8
|
73.3 lbs.
Standard Deviation 29.3
|
66.4 lbs.
Standard Deviation 31.3
|
72.9 lbs.
Standard Deviation 37
|
71.6 lbs.
Standard Deviation 30
|
66.9 lbs.
Standard Deviation 31.5
|
|
Maximum Grip Strength, Treated Subjects
Week 12
|
78.9 lbs.
Standard Deviation 29.9
|
68.6 lbs.
Standard Deviation 31.2
|
81.8 lbs.
Standard Deviation 39.7
|
74.5 lbs.
Standard Deviation 32.8
|
65.1 lbs.
Standard Deviation 30
|
|
Maximum Grip Strength, Treated Subjects
Week 24
|
82.5 lbs.
Standard Deviation 32.7
|
71 lbs.
Standard Deviation 32.5
|
80.7 lbs.
Standard Deviation 33.7
|
77.8 lbs.
Standard Deviation 27
|
76.4 lbs.
Standard Deviation 30.9
|
Adverse Events
Placebo Control
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
0.45 mg rhPDGF-BB
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
0.75 mg rhPDGF-BB
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
1.5 mg rhPDGF-BB
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
3.0 mg rhPDGF-BB
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Control
n=20 participants at risk
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
Placebo: sodium acetate buffer (0 mg rhPDGF-BB)
|
0.45 mg rhPDGF-BB
n=20 participants at risk
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 participants at risk
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 participants at risk
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 participants at risk
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
General disorders
Injection site calcification
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
Other adverse events
| Measure |
Placebo Control
n=20 participants at risk
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
Placebo: sodium acetate buffer (0 mg rhPDGF-BB)
|
0.45 mg rhPDGF-BB
n=20 participants at risk
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
0.75 mg rhPDGF-BB
n=20 participants at risk
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
1.5 mg rhPDGF-BB
n=20 participants at risk
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
3.0 mg rhPDGF-BB
n=20 participants at risk
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
|
|---|---|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Lip dry
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Feeling hot
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site calcification
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site coldness
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site discolouration
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site discomfort
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site erythema
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site haematoma
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site haemorrhage
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site inflammation
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site mass
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site pain
|
15.0%
3/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
40.0%
8/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
25.0%
5/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
30.0%
6/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
60.0%
12/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site pruritus
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site rash
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site swelling
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
30.0%
6/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
15.0%
3/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Injection site warmth
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Oedema peripheral
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
General disorders
Tenderness
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Parotitis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Tooth infection
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Back injury
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Conjunctival abrasion
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
15.0%
3/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
35.0%
7/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Investigations
Renal function test abnormal
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
30.0%
6/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
45.0%
9/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
25.0%
5/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint crepitation
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
15.0%
3/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
15.0%
3/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
30.0%
6/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Joint warmth
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
15.0%
3/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Hypoaesthesia
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
10.0%
2/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
20.0%
4/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Surgical and medical procedures
Female sterilisation
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
5.0%
1/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
0.00%
0/20 • Patients were assessed through study completion scheduled at 24 weeks following surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place