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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Northwestern Ophthalmic Institute S.C..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov Identifier:
NCT00253799
First received: November 10, 2005
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2 intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in patients with painful glenohumeral osteoarthritis.


Condition Intervention Phase
Painful Shoulder Osteoarthritis
Device: Hylan GF-20
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Single Arm, Pilot Study Evaluating the Safety and Efficacy of Hyaluronan (Hylan GF-20) in Patients With Painful Shoulder Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Northwestern Ophthalmic Institute S.C.:

Primary Outcome Measures:
  • -Change from baseline to week 26 evaluation of patient's assessment of pain (VAS rest, motion, night)
  • -Change from Baseline to follow-up in overall pain and function (WOMAC shoulder rating questionnaire)

Secondary Outcome Measures:
  • -Absolute change in passive range of motion, in flexion, abduction, internal and external rotation
  • -Requirements for rescue medication use for pain of the shoulder at each scheduled visit

Estimated Enrollment: 35
Study Start Date: December 2005
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Be will and able to provide written informed consent prior to any study-related procedures being performed and able to understand and comply with the requirements of this study.

    • Agree to receive fluoroscopically guided injections.
    • Be men or women aged 35 years or older.
    • If female and of childbearing age, must have a negative pregnancy test and have taken oral contraceptives for at least one month prior to treatment and continue for the duration of the study (up to and including the final study visit) or agree to use 2 forms of contraception; otherwise females must be surgically sterile or postmenopausal for at least one year.
    • Have painful, non-inflammatory unilateral osteoarthritis of the shoulder. OA in the contralateral shoulder is permissible provided that the OA symptoms are greater in the study joint. The presence of soft tissue pathology (e.g., rotator cuff tear) is permitted, and will be evaluated by an MRI (taken within 6 months of study entry).
    • Report an initial visual analogue pain score (VAS) of ≥ 30 and ≤ 80.
    • Have radiographic confirmation of osteoarthritis of the shoulder prior to baseline (modified Kellgren and Lawrence Numerical Grading System Grades II – IV) on radiographs performed within 12 weeks of screening
    • Have pain from shoulder OA requiring frequent (> 3 days/week) use of analgesics or NSAIDs for at least 8 weeks prior to screening.

Exclusion Criteria:

  • • Pregnant, lactating, or unwilling to use adequate contraception.

    • Prior viscosupplementation in target shoulder joint within 1 year of study entry.
    • Known sensitivity to avian protein or any components of hyaluronan based infection devices, steroids, lidocaine.
    • Known Sensitivity to contrast agent.
    • Used systemic steroids or have had an intra-articular steroid injection in the target shoulder within the last 3 months.
    • Rapidly progressive disease.
    • Acute disease or trauma leading to osteoarthritis of the joint within 2 years of study entry.
    • Presence of a primary inflammatory arthropathy (e.g., rheumatoid, psoriatic, or gouty arthritis).
    • Active skin or soft tissue infection in the area of the injection site.
    • Cervical spin disorders (e.g., radiculopathy) that have been symptomatic and required active treatment within the past 3 months.
    • Any active musculoskeletal condition that would impede measurement of the efficacy of the target shoulder joint (such as fibromyalgia).
    • Any major surgery, arthroplasty or arthroscopy in the target shoulder within 26 weeks of screening or planned surgery within the duration of the study.
    • Septic arthritis in any joints within 3 months prior to screening; any history of septic arthritis in the target shoulder.
    • Any significant chronic skin disorders that could interfere with the evaluation of the injection site.
    • Uncontrolled diabetes mellitus, diabetic neuropathy or infectious complications.
    • Active malignancy receiving treatment.
    • Taking warfarin or parental anticoagulant therapy.
    • Active asthma that may require periodic treatment with steroids during the study period.
    • Use of investigational drug, device, or biologic within 12 weeks of screening
    • Patients with ongoing litigation or workman’s compensation claim.
  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: NCT00253799

Sponsors and Collaborators
Northwestern Ophthalmic Institute S.C.
Investigators
Principal Investigator: Victoria A Brander, MD Northwestern Ophthalmic Institute S.C.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00253799     History of Changes
Other Study ID Numbers: 0133-003
Study First Received: November 10, 2005
Last Updated: June 21, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 22, 2014