- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00198029
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
March 20, 2017 updated by: Hospital for Special Surgery, New York
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilot Study of Hylan G-F 20
32 Subjects have received Synvisc Injections and followed for 6 months.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Disabilities of the Arm, Shoulder and Hand Outcome Measure
Time Frame: 26 weeks (6 months)
|
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.
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26 weeks (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale for Pain
Time Frame: 26 weeks (6 months)
|
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.
|
26 weeks (6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa Mandl, MD MPH, Hospital for Special Surgery, New York
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Actual)
April 17, 2017
Last Update Submitted That Met QC Criteria
March 20, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23034
- 101584
- Grant# K23AR050607-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpometacarpal Osteoarthritis
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University of MinnesotaRecruitingThumb Carpometacarpal Osteoarthritis | Thumb Basal Joint OsteoarthritisUnited States
-
Indiana Hand to Shoulder CenterCTM BiomedicalEnrolling by invitationOsteoarthritis | Osteoarthritis Thumb Base Joint | Carpometacarpal Osteoarthritis | ThumbUnited States
-
Mayo ClinicCompletedThumb Carpometacarpal Joint OsteoarthritisUnited States
-
Medical University of WarsawNot yet recruitingThumb Osteoarthritis | Rhizarthrosis | Carpometacarpal OsteoarthritisPoland
-
IsalaUnknownTrapeziometacarpal Osteoarthritis | Thumb Carpometacarpal OsteoarthritisNetherlands
-
IsalaUnknownTrapeziometacarpal Osteoarthritis | Thumb Carpometacarpal OsteoarthritisNetherlands
-
Indiana Hand to Shoulder CenterRecruitingCarpometacarpal OsteoarthritisUnited States
-
University of FloridaNational Center for Advancing Translational Sciences (NCATS)Recruiting
-
University of AlbertaRecruitingThumb Osteoarthritis | Osteoarthritis of the Carpometacarpal JointCanada
-
Marie BadalamenteRecruitingCarpometacarpal (CMC) OsteoarthritisUnited States
Clinical Trials on Synvisc (hylan G-F20)
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PulsalysArtialisCompletedKnee Osteoarthritis | Intra-Articular InjectionBelgium
-
Genzyme, a Sanofi CompanyCompletedOsteoarthritis, HipUnited States, Canada
-
Grant JonesGenzyme, a Sanofi CompanyWithdrawnArthralgiaUnited States
-
Genzyme, a Sanofi CompanyCompletedMusculoskeletal Diseases | Osteoarthritis, KneeBelgium, United Kingdom, France, Netherlands, Czech Republic, Germany
-
University of CalgaryUnknownPatellofemoral Pain SyndromeCanada
-
SanofiCompleted
-
Genzyme, a Sanofi CompanyCompletedMusculoskeletal Diseases | OsteoarthritisFrance, Germany
-
Genzyme, a Sanofi CompanyCompletedOsteoarthritisNetherlands, Germany, Italy
-
Genzyme, a Sanofi CompanyCompleted
-
Fundación Pública Andaluza Progreso y SaludCompleted