An Open Label Trial for Treating Carpometacarpal Osteoarthritis of the Thumb: Pilot Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Hospital for Special Surgery, New York.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Hospital for Special Surgery, New York
Collaborators:
Genzyme
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00198029
First received: September 13, 2005
Last updated: January 27, 2009
Last verified: January 2009
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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) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
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 |
|---|---|
|
No Intervention: Control
We are looking at 20 control subjects who do not have CMC OA and how they perform on the Strength-Dexterity test.
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|
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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 Baranchuk | 212-774-2960 | baranchukn@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
Investigators
| Principal Investigator: | Lisa Mandl, MD MPH | Hospital for Special Surgery, New York |
More Information
No publications provided by Hospital for Special Surgery, New York
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lisa Mandl MD, Hospital for Special Surgery |
| ClinicalTrials.gov Identifier: | NCT00198029 History of Changes |
| Other Study ID Numbers: | 23034, 101584, Grant# K23AR050607-01 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 27, 2009 |
| 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 |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013