An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pilot Study of Hylan G-F 20 32 Subjects have received Synvisc Injections and followed for 6 months. |
Device: 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital for Special Surgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
- Genzyme, a Sanofi Company
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Lisa Mandl, MD MPH, Hospital for Special Surgery, New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23034
- 101584
- Grant# K23AR050607-01
Study Results
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 Detail | 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. |
| Arm/Group Title | Synvisc Group |
|---|---|
| Arm/Group Description | Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections. |
| Period Title: Overall Study | |
| STARTED | 32 |
| COMPLETED | 28 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Open Label Group |
|---|---|
| Arm/Group Description | Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections. |
| Overall Participants | 32 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
16
50%
|
| >=65 years |
16
50%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
64
(8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
22
68.8%
|
| Male |
10
31.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
32
100%
|
Outcome Measures
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Synvisc Group |
|---|---|
| Arm/Group Description | Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections. |
| Measure Participants | 32 |
| Mean (Standard Deviation) [units on a scale] |
12.6
(17.2)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Synvisc Group |
|---|---|
| Arm/Group Description | Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections. |
| Measure Participants | 32 |
| Mean (Standard Deviation) [mm] |
15.2
(29.5)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Open Label Group | |
| Arm/Group Description | Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections. | |
All Cause Mortality |
||
| Open Label Group | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Open Label Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/32 (9.4%) | |
| Gastrointestinal disorders | ||
| Unlikely Related GI Bleed | 1/32 (3.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Unlikely Related Pseudogout | 1/32 (3.1%) | 1 |
| Possibly but Unlikely Related Fall | 1/32 (3.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Open Label Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/32 (9.4%) | |
| Musculoskeletal and connective tissue disorders | ||
| Pain at Injection Site | 3/32 (9.4%) | 96 |
Limitations/Caveats
More Information
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 | 212-774-2555 |
| MandlL@hss.edu |
- 23034
- 101584
- Grant# K23AR050607-01