Trial Outcomes & Findings for A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb (NCT NCT00398866)
NCT ID: NCT00398866
Last Updated: 2017-07-07
Results Overview
Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Baseline, 26 Weeks
Results posted on
2017-07-07
Participant Flow
Patients were recruited from the practices of Hospital for Special Surgery (HSS) physicians or were or self-referred. Study information was posted on the HSS website, clinicaltrials.gov, Craig's List and local newspapers. Recruitment occurred between 05/25/2007 and 07/15/2009.
396 subjects screened 169 did not meet eligibility criteria 27 declined injection 200 subjects randomized
Participant milestones
| Measure |
Bupivicaine
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
68
|
66
|
|
Overall Study
COMPLETED
|
52
|
60
|
58
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
8
|
Reasons for withdrawal
| Measure |
Bupivicaine
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
2
|
|
Overall Study
Unable to complete requirements of study
|
1
|
1
|
1
|
Baseline Characteristics
A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
Baseline characteristics by cohort
| Measure |
Bupivicaine
n=66 Participants
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
n=68 Participants
Corticosteroid (trimcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
n=66 Participants
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
66.7 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
50 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · No data
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
58 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · No data
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 26 WeeksPopulation: Patients who completed follow-up through 26 weeks
Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.
Outcome measures
| Measure |
Bupivicaine
n=61 Participants
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
n=65 Participants
Corticosteroid (trimcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
n=62 Participants
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
|---|---|---|---|
|
Pain Visual Analogue Scale (VAS)
Pain VAS at Baseline
|
57.1 Units on a scale
Standard Deviation 20.1
|
63.2 Units on a scale
Standard Deviation 20.2
|
60.7 Units on a scale
Standard Deviation 19.3
|
|
Pain Visual Analogue Scale (VAS)
Pain VAS at 26 weeks
|
42.9 Units on a scale
Standard Deviation 26.5
|
50.1 Units on a scale
Standard Deviation 29.4
|
49.8 Units on a scale
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Baseline, 26 WeeksPopulation: Patients who completed follow-up through 26 weeks
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire measures degree of disability on a scale of 0 to 100, with a higher score indicating greater disability.
Outcome measures
| Measure |
Bupivicaine
n=61 Participants
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
n=65 Participants
Corticosteroid (trimcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
n=62 Participants
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
|---|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Dash at 26 Weeks
|
24.2 units on a scale
Standard Deviation 17.4
|
27.0 units on a scale
Standard Deviation 18.0
|
26.1 units on a scale
Standard Deviation 19.0
|
|
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
DASH at Baseline
|
25.7 units on a scale
Standard Deviation 17.1
|
28.9 units on a scale
Standard Deviation 17.9
|
28.8 units on a scale
Standard Deviation 17.3
|
Adverse Events
Bupivicaine
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Triamcinolone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Hylan G-F 20
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivicaine
n=66 participants at risk
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
n=68 participants at risk
Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
n=66 participants at risk
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall--hand injury
|
1.5%
1/66 • Number of events 1
|
0.00%
0/68
|
0.00%
0/66
|
|
Gastrointestinal disorders
Emergency Cholecystecomy
|
0.00%
0/66
|
0.00%
0/68
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Mitral Valve Surgery
|
0.00%
0/66
|
0.00%
0/68
|
1.5%
1/66 • Number of events 1
|
Other adverse events
| Measure |
Bupivicaine
n=66 participants at risk
Bupivicaine (local anesthetic)
Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks
|
Triamcinolone
n=68 participants at risk
Corticosteroid (triamcinolone (Kenalog) 40 mg)
Kenalog (triamcinolone; corticosteroid injection): 1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
|
Hylan G-F 20
n=66 participants at risk
Synvisc
Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Atrophy or Depigmentation
|
0.00%
0/66
|
5.9%
4/68 • Number of events 4
|
0.00%
0/66
|
|
Musculoskeletal and connective tissue disorders
Pain, Swelling, or Numbness in Hand
|
3.0%
2/66 • Number of events 2
|
4.4%
3/68 • Number of events 3
|
3.0%
2/66 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin and Nail Abnormalities
|
0.00%
0/66
|
2.9%
2/68 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
|
Immune system disorders
Positive ANA Test (Previous status unknown)
|
0.00%
0/66
|
1.5%
1/68 • Number of events 1
|
0.00%
0/66
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place