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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb

NCT00398866

Osteoarthritis

COMPLETED PHASE3

A Safety Study of Hylan GF-20 to Treat Shoulder Osteoarthritis

NCT00253799

Painful Shoulder Osteoarthritis

UNKNOWN PHASE4

Effects of Synvisc on Cartilage in Knee Osteoarthritis (OA)

NCT00949494

Osteoarthritis

COMPLETED PHASE1

Study of Safety and Efficacy of 6 mL Synvisc-One (Hylan G-F 20) in Indian Patients With Symptomatic Osteoarthritis of Knee(s) After Initial and Repeat Treatment

NCT02389452

Osteoarthritis

COMPLETED PHASE4

Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis

NCT06913088

Hand Arthritis

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpometacarpal Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pilot Study of Hylan G-F 20

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

Group Type EXPERIMENTAL

Synvisc (hylan G-F20)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No