Back to resultsAn Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Primary Purpose
Carpometacarpal Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Synvisc (hylan G-F20)
Sponsored by
About this trial
This is an interventional other trial for Carpometacarpal Osteoarthritis focused on measuring Osteoarthritis, Hyaluronan, Carpometacarpal, Outcomes
Eligibility Criteria
Inclusion Criteria: Radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the Carpometacarpal joint Patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of NSAIDS If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study. Proficiency in English. Exclusion Criteria: Previous bad injury to the thumb Previous hand surgery on the study thumb Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc) Rheumatoid arthritis or lupus Bleeding problems Being on blood thinners (except aspirin) Known allergies to any of the medications being used Allergies to chicken products Current use of oral steroids Cancer that is not cured or in remission Severe diabetes A serious infection somewhere else in the subject's body
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot Study of Hylan G-F 20
Arm Description
32 Subjects have received Synvisc Injections and followed for 6 months.
Outcomes
Primary Outcome Measures
The Disabilities of the Arm, Shoulder and Hand Outcome Measure
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.
Secondary Outcome Measures
Visual Analog Scale for Pain
The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.
Full Information
NCT ID
NCT00198029
First Posted
September 13, 2005
Last Updated
March 20, 2017
Sponsor
Hospital for Special Surgery, New York
Collaborators
Genzyme, a Sanofi Company, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00198029
Brief Title
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Official Title
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Genzyme, a Sanofi Company, National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out if hyaluronan, an injectable medication for knee arthritis, also works for arthritis at the base of the thumb. This study will also evaluate how good ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpometacarpal Osteoarthritis
Keywords
Osteoarthritis, Hyaluronan, Carpometacarpal, Outcomes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot Study of Hylan G-F 20
Arm Type
Experimental
Arm Description
32 Subjects have received Synvisc Injections and followed for 6 months.
Intervention Type
Device
Intervention Name(s)
Synvisc (hylan G-F20)
Intervention Description
32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection
Primary Outcome Measure Information:
Title
The Disabilities of the Arm, Shoulder and Hand Outcome Measure
Description
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded.
Time Frame
26 weeks (6 months)
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain
Description
The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded.
Time Frame
26 weeks (6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the Carpometacarpal joint
Patient complaint of unacceptable pain despite modification of activity, a trial of splinting and a therapeutic dose of NSAIDS
If bilateral disease, only the most severely involved hand, (as defined by VAS for pain), will be entered in the study.
Proficiency in English.
Exclusion Criteria:
Previous bad injury to the thumb
Previous hand surgery on the study thumb
Known hand comorbidities (i.e. carpal tunnel syndrome, de Quervains Tenosynovitis etc)
Rheumatoid arthritis or lupus
Bleeding problems
Being on blood thinners (except aspirin)
Known allergies to any of the medications being used
Allergies to chicken products
Current use of oral steroids
Cancer that is not cured or in remission
Severe diabetes
A serious infection somewhere else in the subject's body
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Mandl, MD MPH
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19601706
Citation
Mandl LA, Hotchkiss RN, Adler RS, Lyman S, Daluiski A, Wolfe SW, Katz JN. Injectable hyaluronan for the treatment of carpometacarpal osteoarthritis: open label pilot trial. Curr Med Res Opin. 2009 Sep;25(9):2103-8. doi: 10.1185/03007990903084016.
Results Reference
derived
Learn more about this trial
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
We'll reach out to this number within 24 hrs