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Trial record 39 of 75 for:    "Collagen Disease" | "Triamcinolone"

A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb

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ClinicalTrials.gov Identifier: NCT00398866
Recruitment Status : Completed
First Posted : November 14, 2006
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Synvisc (Hylan G-F20; hyaluronan injection)
Drug: Bupivicaine (local anesthesia injection)
Drug: Kenalog (triamcinolone; corticosteroid injection)
Enrollment 200
Recruitment Details 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.
Pre-assignment Details 396 subjects screened 169 did not meet eligibility criteria 27 declined injection 200 subjects randomized
Arm/Group Title Bupivicaine Triamcinolone Hylan G-F 20
Hide Arm/Group Description

Bupivicaine (local anesthetic)

Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks

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

Synvisc

Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Period Title: Overall Study
Started 66 68 66
Completed 52 60 58
Not Completed 14 8 8
Reason Not Completed
Adverse Event             1             0             0
Lack of Efficacy             0             0             1
Lost to Follow-up             7             6             4
Withdrawal by Subject             5             1             2
Unable to complete requirements of study             1             1             1
Arm/Group Title Bupivicaine Triamcinolone Hylan G-F 20 Total
Hide Arm/Group Description

Bupivicaine (local anesthetic)

Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks

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

Synvisc

Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Total of all reporting groups
Overall Number of Baseline Participants 66 68 66 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 68 participants 66 participants 200 participants
66.3  (9.3) 66.6  (8.4) 67.1  (10.1) 66.7  (9.3)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Gender Number Analyzed 66 participants 68 participants 66 participants 200 participants
Female
50
  75.8%
40
  58.8%
45
  68.2%
135
  67.5%
Male
16
  24.2%
28
  41.2%
20
  30.3%
64
  32.0%
No data
0
   0.0%
0
   0.0%
1
   1.5%
1
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 66 participants 68 participants 66 participants 200 participants
White
58
  87.9%
61
  89.7%
61
  92.4%
180
  90.0%
Other
8
  12.1%
7
  10.3%
4
   6.1%
19
   9.5%
No data
0
   0.0%
0
   0.0%
1
   1.5%
1
   0.5%
1.Primary Outcome
Title Pain Visual Analogue Scale (VAS)
Hide Description Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.
Time Frame Baseline, 26 Weeks
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Hide Analysis Population Description
Patients who completed follow-up through 26 weeks
Arm/Group Title Bupivicaine Triamcinolone Hylan G-F 20
Hide Arm/Group Description:

Bupivicaine (local anesthetic)

Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks

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

Synvisc

Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Overall Number of Participants Analyzed 61 65 62
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pain VAS at Baseline 57.1  (20.1) 63.2  (20.2) 60.7  (19.3)
Pain VAS at 26 weeks 42.9  (26.5) 50.1  (29.4) 49.8  (26.3)
2.Secondary Outcome
Title Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Hide Description 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.
Time Frame Baseline, 26 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed follow-up through 26 weeks
Arm/Group Title Bupivicaine Triamcinolone Hylan G-F 20
Hide Arm/Group Description:

Bupivicaine (local anesthetic)

Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks

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

Synvisc

Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Overall Number of Participants Analyzed 61 65 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
DASH at Baseline 25.7  (17.1) 28.9  (17.9) 28.8  (17.3)
Dash at 26 Weeks 24.2  (17.4) 27.0  (18.0) 26.1  (19.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupivicaine Triamcinolone Hylan G-F 20
Hide Arm/Group Description

Bupivicaine (local anesthetic)

Bupivicaine (local anesthesia injection): 1 ml of bupivicaine 0.5% injected once a week for 2 weeks

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

Synvisc

Synvisc (Hylan G-F20; hyaluronan injection): 1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

All-Cause Mortality
Bupivicaine Triamcinolone Hylan G-F 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bupivicaine Triamcinolone Hylan G-F 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/66 (1.52%)      0/68 (0.00%)      2/66 (3.03%)    
Cardiac disorders       
Mitral Valve Surgery  0/66 (0.00%)  0 0/68 (0.00%)  0 1/66 (1.52%)  1
Gastrointestinal disorders       
Emergency Cholecystecomy  0/66 (0.00%)  0 0/68 (0.00%)  0 1/66 (1.52%)  1
Injury, poisoning and procedural complications       
Fall--hand injury  1/66 (1.52%)  1 0/68 (0.00%)  0 0/66 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupivicaine Triamcinolone Hylan G-F 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/66 (3.03%)      10/68 (14.71%)      3/66 (4.55%)    
Immune system disorders       
Positive ANA Test (Previous status unknown)  0/66 (0.00%)  0 1/68 (1.47%)  1 0/66 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Pain, Swelling, or Numbness in Hand  2/66 (3.03%)  2 3/68 (4.41%)  3 2/66 (3.03%)  2
Skin and subcutaneous tissue disorders       
Skin Atrophy or Depigmentation  0/66 (0.00%)  0 4/68 (5.88%)  4 0/66 (0.00%)  0
Skin and Nail Abnormalities  0/66 (0.00%)  0 2/68 (2.94%)  2 1/66 (1.52%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lisa Mandl
Organization: Hospital for Special Surgery
Phone: 2127742754
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00398866     History of Changes
Other Study ID Numbers: K23AR050607 ( U.S. NIH Grant/Contract )
K23AR050607 ( U.S. NIH Grant/Contract )
5K23AR050607-04 ( U.S. NIH Grant/Contract )
26043 ( Other Identifier: HSS IRB )
First Submitted: November 10, 2006
First Posted: November 14, 2006
Results First Submitted: April 4, 2017
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017