Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT00398866
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
95 Years
Study:
NCT00398866
Study Brief:
Protocol Section:
NCT00398866