An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Carpometacarpal Osteoarthritis Clinical Trial

Official title:

An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00198029
• Other study ID #: 23034
• Secondary ID: 101584Grant# K23
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 3, 2013
• Start date: October 2004
• Est. completion date: December 2009

Study information

• Verified date: May 2013
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 95 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Carpometacarpal Osteoarthritis
• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Genzyme, a Sanofi Company, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	26 weeks (6 months)	No
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.	26 weeks (6 months)	No