Carpometacarpal OsteoarthritisNCT00198029
An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
A study testing Synvisc (hylan G-F20) in people with Carpometacarpal Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Carpometacarpal Osteoarthritis
- What is being tested?
- Synvisc (hylan G-F20)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
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.
- Conditions
- Carpometacarpal Osteoarthritis
- Being tested
- Synvisc (hylan G-F20)
- Keywords
- Osteoarthritis, Hyaluronan, Carpometacarpal, Outcomes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synvisc (hylan G-F20)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Pilot Study of Hylan G-F 20 | Experimental | 32 Subjects have received Synvisc Injections and followed for 6 months. Receives: Device: Synvisc (hylan G-F20) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks (6 months)
Secondary outcomes (1)
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.
Measured: 26 weeks (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpometacarpal OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Lisa Mandl, MD MPH, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198029
- Sponsor's protocol ID
- 23034
- Other IDs
- 101584, Grant# K23AR050607-01
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19601706
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
- ClinicalTrials.gov ID
- NCT00198029
- Acronym / sponsor ID
- 23034
- Conditions
- Carpometacarpal Osteoarthritis
- Keywords
- Osteoarthritis, Hyaluronan, Carpometacarpal, Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, National Institutes of Health (NIH)
- Study start
- Oct 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 10 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Study of Hylan G-F 20 | Experimental | Device: Synvisc (hylan G-F20)32 Subjects have received Synvisc Injections and followed for 6 months. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synvisc (hylan G-F20)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 | Device | Pilot Study of Hylan G-F 20 |
Primary outcome
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.
1 secondary outcome
Visual Analog Scale for Pain
Time frame: 26 weeks (6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19601706Mandl 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.
Related trials for Carpometacarpal Osteoarthritis
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ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
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Ketorolac in Upper Extremity Tendinopathy and Arthropathy
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Study on Basal Joint Arthritis Prospective
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Mandl, MD MPH principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synvisc (hylan G-F20) in people with Carpometacarpal Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Disabilities of the Arm, Shoulder and Hand Outcome Measure (time frame: 26 weeks (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.