Carpometacarpal Osteoarthritis
Conditions
Keywords
Osteoarthritis, Hyaluronan, Carpometacarpal, Outcomes
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.
Interventions
DEVICESynvisc (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
Sponsors
Genzyme, a Sanofi Company
National Institutes of Health (NIH)
Hospital for Special Surgery, New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand Outcome Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale for Pain | 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. |
Countries
United States
Participant flow
Recruitment details
Patients with painful CMC OA and radiographic changes of Kellgren and Lawrence (K+L) Grade 2-4 were recruited from rheumatology and hand surgery practices at the Hospital for Special Surgery from 2004-2005
Pre-assignment details
Exclusion criteria included: age \< 45, systemic rheumatic disease, self-reported comorbid hand conditions, history of gout or pseudogout, bleeding diatheses, previous surgery to the involved thumb, and no evidence of CMC joint space narrowing. Patients must have failed some form of conservative therapy, such as NSAIDS, acetaminophen or splinting.
Participants by arm
| Arm | Count |
|---|---|
| Open Label Group Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections. | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Open Label Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 32 |
| serious Total, serious adverse events | 3 / 32 |
Outcome results
Primary
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.
Time frame: 26 weeks (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc Group | The Disabilities of the Arm, Shoulder and Hand Outcome Measure | 12.6 units on a scale | Standard Deviation 17.2 |
Secondary
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.
Time frame: 26 weeks (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Synvisc Group | Visual Analog Scale for Pain | 15.2 mm | Standard Deviation 29.5 |