Trial record 1 of 1 for:    NCT00398866
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A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Dr. Lisa Mandl, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00398866
First received: November 10, 2006
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic.

The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections (local anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with corticosteroid injections will result in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections. Patients with worse pre-treatment function will have less improvement and worse post-treatment results after administration of corticosteroid or hyaluronan.


Condition Intervention Phase
Osteoarthritis
Drug: Synvisc (Hylan G-F20; hyaluronan injection)
Drug: Bupivicaine (local anesthesia injection)
Drug: Kenalog (triamcinolone; corticosteroid injection)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Hyaluronan (Synvisc) for the Treatment of Osteoarthritis in the Thumb: Randomized Control Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disabilities of the arm, shoulder, and hand outcome measure [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analog scale for pain [ Time Frame: Measured during the 6-month duration of participation ] [ Designated as safety issue: No ]

Estimated Enrollment: 213
Study Start Date: August 2006
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bupivicaine (local anesthetic)
Drug: Bupivicaine (local anesthesia injection)
1 ml of bupivicaine 0.5% injected once a week for 2 weeks
Active Comparator: 2
Corticosteroid (trimcinolone (Kenalog) 40 mg)
Drug: Kenalog (triamcinolone; corticosteroid injection)
1 ml (40mg) of triamcinolone (Kenalog) injected the first week, followed by a placebo injection of 1 ml 0.5% bupivacaine the second week; Kenalog is a non-suspension steroid preparation and is less likely to cause post-injection flares than a suspension preparation
Experimental: 3
Synvisc
Drug: Synvisc (Hylan G-F20; hyaluronan injection)
1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks
Other Name: Synvisc, Hyalgan, Hyaluronic Acid

Detailed Description:

Osteoarthritis involves a wearing down of the cartilage within a joint. It can affect any joint in the body, but it most commonly affects joints in the hands, hips, knees, and spine. Over the last few years, a new medicine called hyaluronan has been used for treating osteoarthritis. Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic. Specifically, the study will evaluate pain relief, patient satisfaction, and functional outcomes among participants.

Participation in this study will last 26 weeks. Screening will include a questionnaire and an x-ray of the affected thumb. Eligible participants will then be randomly assigned to one of three treatments: two hyaluronan injections, one corticosteroid injection plus one local anesthetic injection, or two local anesthetic injections. Participants will receive the injections at the base of their thumb, and the first injection will be followed by the second injection a week later. There will be five study visits that will occur at baseline and Weeks 2, 4, 12, and 26. All study visits will include questionnaires, and except for the Week 2 study visit, they will also include an examination and evaluation of the affected thumb. Photographs of the thumb will be taken at baseline. The injections will occur at baseline and Week 2. At Weeks 8 and 20, questionnaires will be mailed to participants for them to complete. Upon completing the study, participants will have the option of receiving continued treatment with another round of hyaluronic injections.

  Eligibility

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

Inclusion Criteria:

  • Presence of osteophytes or sclerosis at the carpometacarpal (CMC) joint
  • Complaint of unacceptable pain despite modification of activity and a therapeutic dose of nonsteroidal anti-inflammatory drugs (NSAIDS), if tolerated
  • If bilateral disease, only the most severely involved hand (as defined by the visual analog scale [VAS] for pain) will be entered in the study
  • Able to follow instructions and complete questionnaires
  • Failed conservative therapy with NSAIDS or COX-2 inhibitors
  • Unable to tolerate COX-2 inhibitors

Exclusion Criteria:

  • Previous traumatic dislocation, ligament tear, or fracture of the thumb in the affected hand
  • Previous hand surgery on the affected hand
  • Known hand comorbidities (e.g., active carpal tunnel syndrome, de Quervains tenosynovitis, etc.)
  • Systemic rheumatic disease
  • Bleeding diatheses or anti-coagulation
  • Allergies to steroids, chicken products, bupivicaine, or adhesive (e.g., double-sided tape)
  • Current use of oral or intravenous steroids
  • Active systemic malignancies
  • Hyaluronan injection in the target CMC joint in the last 6 months
  • Steroid or hyaluronan injection in any other joint in the last 6 months
  • Insulin dependent diabetes mellitus (IDDM)
  • Active infection
  • Pain in the index joint that is more than 40 out of 100 on a VAS Pain scale
  • End Stage CMC osteoarthritis, equivalent to bone on bone, Kellgren and Lawrence Stage IV
  • Grade 3 or 4 Eaton and Litter (E+L) Classification
  • E+L 3: Advanced joint distraction, subchondral cysts, and sclerosis
  • E+L 4: Involvement of several joint surfaces
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398866

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Lisa A. Mandl, MD, MPH Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Dr. Lisa Mandl, Assistant Attending Physician, Hospital for Special Surgery, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00398866     History of Changes
Other Study ID Numbers: K23 AR050607, K23AR050607, 5K23AR050607-04, 26043
Study First Received: November 10, 2006
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospital for Special Surgery, New York:
Hyaluronan
Carpometacarpal
Outcomes
Carpometacarpal Joints

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Bupivacaine
Hyaluronic Acid
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone diacetate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Immunologic
Immunologic Factors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014