NCT00198029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

June 10, 2013

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

5.2 years

First QC Date

September 13, 2005

Results QC Date

January 31, 2013

Last Update Submit

March 20, 2017

Conditions

Carpometacarpal Osteoarthritis

Keywords

OsteoarthritisHyaluronanCarpometacarpalOutcomes

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Visual Analog Scale for Pain

    26 weeks (6 months)

Study Arms (1)

Pilot Study of Hylan G-F 20

EXPERIMENTAL

32 Subjects have received Synvisc Injections and followed for 6 months.

Device: Synvisc (hylan G-F20)

Interventions

Synvisc (hylan G-F20)DEVICE

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

Pilot Study of Hylan G-F 20

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

  • Mandl LA, Hotchkiss RN, Adler RS, Lyman S, Daluiski A, Wolfe SW, Katz JN. Injectable hyaluronan for the treatment of carpometacarpal osteoarthritis: open label pilot trial. Curr Med Res Opin. 2009 Sep;25(9):2103-8. doi: 10.1185/03007990903084016.

    PMID: 19601706DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr. Lisa Mandl
Organization
Hospital for Special Surgery
MandlL@hss.edu
212-774-2555

Study Officials

  • Lisa Mandl, MD MPH

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 17, 2017

Results First Posted

June 10, 2013

Record last verified: 2017-03

Locations

US(1)