Loading clinical trials...

A Safety Study of Hylan GF-20 to Treat Shoulder Osteoarthritis | Clinical Trials | Clareo Health

UNKNOWNPHASE4

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

Prospective, Single Arm, Pilot Study Evaluating the Safety and Efficacy of Hyaluronan (Hylan GF-20) in Patients With Painful Shoulder Osteoarthritis

NCT00253799•Northwestern Ophthalmic Institute S.C.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

35 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+10 more criteria

Key Dates

Start Date

December 1, 2005

Last Updated

June 25, 2007

Enrollment

ESTIMATED participants

Conditions

Painful Shoulder Osteoarthritis

Interventions

Hylan GF-20

DEVICE