An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study - Full Text View

Sponsors and Collaborators:	Hospital for Special Surgery, New York Genzyme National Institutes of Health (NIH)
Information provided by:	Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:	NCT00198029

Purpose

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.

In a sub-study including 20 age-matched subjects without arthritis to validate the manual Strength-Dexterity Test. We are currently recruiting subjects without arthritis for our control sub-study.

Condition	Intervention
Carpometacarpal Osteoarthritis	Device: Synvisc (hylan G-F20)

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Label Trial for Treating Carpometacarpal Osteoarthritis: A Pilot Study Sub Study: Validation of the Strength-Dexterity Test in Subjects Without Carpometacarpal Osteoarthritis

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:

The Disabilities of the Arm, Shoulder and Hand Outcome Measure [ Time Frame: Control Subjects: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Analog Scale for Pain [ Time Frame: Control Subjects: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: No Intervention We are looking at 20 control subjects who do not have CMC OA and how they perform on the Strength-Dexterity test.
Pilot Study 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 IA over the course of 3 weeks and then followed for 6 months post injection

Eligibility

Ages Eligible for Study:	45 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Radiographic evidence of at least moderate narrowing (joint space < 1mm) or the presence of osteophytes or sclerosis at the CMC 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198029

Contacts

Contact: Nadia Barunchuk	212-774-2960	barunchukn@hss.edu
Contact: Jason Guardado	212-774-2555	GuardadoJ@hss.edu

Locations

United States, New York
Hospital for Special Surgery	Recruiting
New York, New York, United States, 10021
Contact: Lisa Mandl, MD MPH 212-774-2555
Principal Investigator: Lisa A Mandl, MD MPH
Sub-Investigator: Jeffrey N Katz, MD MS
Sub-Investigator: Robert Hotchkiss, MD
Sub-Investigator: Steven Paget, MD
Sub-Investigator: Ronald S Adler, MD PhD
Sub-Investigator: Francisco Valero-Cuevas, PhD
Sub-Investigator: Scott W Wolfe, MD
Sub-Investigator: Edward A Athanasian, MD
Sub-Investigator: Aaron Daluiski, MD
Sub-Investigator: Michelle Carlson, MD
Sub-Investigator: Sherry Backus, MAPT
Sub-Investigator: Madhusudhan Venkadesan
Sub-Investigator: Stephen Lyman, PhD

Sponsors and Collaborators

Hospital for Special Surgery, New York

Genzyme

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Lisa Mandl, MD MPH

Hospital for Special Surgery

More Information

Responsible Party:	Hospital for Special Surgery ( Lisa Mandl MD )
Study ID Numbers:	23034, 101584, Grant# K23AR050607-01
Study First Received:	September 13, 2005
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00198029
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:

Osteoarthritis
Hyaluronan
Carpometacarpal
Outcomes

Study placed in the following topic categories:

Musculoskeletal Diseases
Hyaluronic Acid
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 15, 2009