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

NCT00398866 | Completed Phase 3 Results DMC

• 3 other identifiers: K23AR0506075K23AR050607-0426043
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Keywords

Hyaluronan; Carpometacarpal; Outcomes; Carpometacarpal Joints

Outcome Measures

Primary Outcomes (1)

• Pain Visual Analogue Scale (VAS)

  Pain intensity measured on a Visual Analog Scale with scores ranging from 0 to 100, with 100 = severe pain.

  Baseline, 26 Weeks

Secondary Outcomes (1)

• Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire

  Baseline, 26 Weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Bupivicaine (local anesthetic)

Drug: Bupivicaine (local anesthesia injection)

2

ACTIVE COMPARATOR

Corticosteroid (trimcinolone (Kenalog) 40 mg)

Drug: Kenalog (triamcinolone; corticosteroid injection)

3

EXPERIMENTAL

Synvisc

Drug: Synvisc (Hylan G-F20; hyaluronan injection)

Interventions

Synvisc (Hylan G-F20; hyaluronan injection) DRUG

1 ml of hyaluronan (Synvisc) injected once a week for 2 consecutive weeks

Also known as: Synvisc, Hyalgan, Hyaluronic Acid

3

Bupivicaine (local anesthesia injection) DRUG

1 ml of bupivicaine 0.5% injected once a week for 2 weeks

1

Kenalog (triamcinolone; corticosteroid injection) DRUG

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

2

Eligibility Criteria

• Age: 45 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

hylan; Hyaluronic Acid; Anesthesia, Local; Triamcinolone Acetonide; Triamcinolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Lisa Mandl
• Organization: Hospital for Special Surgery

MandlL@hss.edu

2127742754

Study Officials

• Lisa A. 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: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2006
• First Posted: November 14, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 7, 2017
• Results First Posted: July 7, 2017

Record last verified: 2017-07

Locations

US (1)