| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10021 |
| Conditions: |
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Osteoarthritis |
| Purpose: |
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Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints
and that is often low in people with osteoarthritis. Although hyaluronan has been used in
millions of people with knee osteoarthritis, it is not yet FDA approved for use in the
thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan
in relieving arthritis symptoms at the base of the thumb and to compare it to
corticosteroids and local anesthetic.
The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal
(CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient
satisfaction, and better functional outcomes than treating with placebo injections (local
anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with
corticosteroid injections will result in greater pain relief, higher patient satisfaction,
and better functional outcomes than treating with placebo injections. Patients with worse
pre-treatment function will have less improvement and worse post-treatment results after
administration of corticosteroid or hyaluronan.
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| Study summary: |
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Osteoarthritis involves a wearing down of the cartilage within a joint. It can affect any
joint in the body, but it most commonly affects joints in the hands, hips, knees, and spine.
Over the last few years, a new medicine called hyaluronan has been used for treating
osteoarthritis. Hyaluronan is a man-made preparation of a protein complex that occurs
naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan
has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for
use in the thumb. The purpose of this study is to determine the safety and effectiveness of
hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to
corticosteroids and local anesthetic. Specifically, the study will evaluate pain relief,
patient satisfaction, and functional outcomes among participants.
Participation in this study will last 26 weeks. Screening will include a questionnaire and
an x-ray of the affected thumb. Eligible participants will then be randomly assigned to one
of three treatments: two hyaluronan injections, one corticosteroid injection plus one local
anesthetic injection, or two local anesthetic injections. Participants will receive the
injections at the base of their thumb, and the first injection will be followed by the
second injection a week later. There will be five study visits that will occur at baseline
and Weeks 2, 4, 12, and 26. All study visits will include questionnaires, and except for the
Week 2 study visit, they will also include an examination and evaluation of the affected
thumb. Photographs of the thumb will be taken at baseline. The injections will occur at
baseline and Week 2. At Weeks 8 and 20, questionnaires will be mailed to participants for
them to complete. Upon completing the study, participants will have the option of receiving
continued treatment with another round of hyaluronic injections. |
| Criteria: |
|
Inclusion Criteria:
- Presence of osteophytes or sclerosis at the carpometacarpal (CMC) joint
- Complaint of unacceptable pain despite modification of activity and a therapeutic
dose of nonsteroidal anti-inflammatory drugs (NSAIDS), if tolerated
- If bilateral disease, only the most severely involved hand (as defined by the visual
analog scale [VAS] for pain) will be entered in the study
- Able to follow instructions and complete questionnaires
- Failed conservative therapy with NSAIDS or COX-2 inhibitors
- Unable to tolerate COX-2 inhibitors
Exclusion Criteria:
- Previous traumatic dislocation, ligament tear, or fracture of the thumb in the
affected hand
- Previous hand surgery on the affected hand
- Known hand comorbidities (e.g., active carpal tunnel syndrome, de Quervains
tenosynovitis, etc.)
- Systemic rheumatic disease
- Bleeding diatheses or anti-coagulation
- Allergies to steroids, chicken products, bupivicaine, or adhesive (e.g., double-sided
tape)
- Current use of oral or intravenous steroids
- Active systemic malignancies
- Hyaluronan injection in the target CMC joint in the last 6 months
- Steroid or hyaluronan injection in any other joint in the last 6 months
- Insulin dependent diabetes mellitus (IDDM)
- Active infection
- Pain in the index joint that is more than 40 out of 100 on a VAS Pain scale
- End Stage CMC osteoarthritis, equivalent to bone on bone, Kellgren and Lawrence Stage
IV
- Grade 3 or 4 Eaton and Litter (E+L) Classification
- E+L 3: Advanced joint distraction, subchondral cysts, and sclerosis
- E+L 4: Involvement of several joint surfaces |
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| Study is available at: |
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Hospital for Special Surgery
New York, NY 10021
United States
Primary Contact:
Tabassum Khan
Email: khant@hss.edu
Phone: 212-774-2960
Secondary Contact:
Tabassum Khan
Email: khant@hss.edu
Phone: 212-774-2960 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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