Clinical trial NCT00436969: ORTHOVISC Shoulder Osteoarthritis Study
Official title: A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glenohumeral Osteoarthritis
Keywords: Orthovisc
Osteoarthritis
Shoulder
Randomized
Lead sponsor: DePuy Mitek
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 274
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

Detailed description: This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.

Eligibility criteria: Inclusion Criteria:

* A candidate for unilateral treatment of osteoarthritis of the shoulder
* Have failed conservative treatment

Exclusion Criteria:

* Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
* No active instability or acute dislocation episodes within the previous 12 months
* Known allergy to hyaluronate preparations
* Pregnant or breast feeding
* Is receiving prescription pain medication for conditions unrelated to the index shoulder condition

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score (Per Protocol)
timeFrame: 6 Months
measure: Visual Analog Scale (VAS) Pain Score (As Treated)
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)
timeFrame: Baseline and 6 months
measure: Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)
timeFrame: Baseline and 6 months
measure: Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)
timeFrame: Baseline and 12 weeks
measure: Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)
timeFrame: Baseline and 12 weeks
measure: American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)
timeFrame: Baseline and 12 weeks
measure: American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)
timeFrame: Baseline and 12 weeks
measure: American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)
timeFrame: Baseline and 6 months
measure: American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)
timeFrame: Baseline and 6 months
measure: Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)
timeFrame: Baseline and 12 weeks
measure: Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)
timeFrame: Baseline and 12 weeks
measure: Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)
timeFrame: Baseline and 6 months
measure: Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)
timeFrame: Baseline and 6 months
measure: 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)
timeFrame: Baseline and 12 weeks
measure: 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)
timeFrame: Baseline and 12 weeks
measure: 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)
timeFrame: Baseline and 6 months
measure: 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)
timeFrame: Baseline and 6 months
measure: 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)
timeFrame: Baseline and 12 weeks
measure: 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)
timeFrame: Baseline and 12 weeks
measure: 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)
timeFrame: Baseline and 6 months
measure: 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: CORE Orthopedics
state: California
city: Fresno
country: United States
facility: Sierra Pacific Orthopaedic Center Medical Group
state: California
city: Coral Gables
country: United States
facility: UHZ Sports Medicine
state: Florida
city: Gulf Breeze
country: United States
facility: Andrews Research Institute
state: Florida
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Worcester
country: United States
facility: University of Massachusetts Merdical School - Worcester
state: Massachusetts
city: St Clair Shores
country: United States
facility: Shores Rheumatology
state: Michigan
city: New York
country: United States
facility: Insall Scott Kelly Institute
state: New York
city: Tulsa
country: United States
facility: Tulsa Bone and Joint
state: Oklahoma
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Houston
country: United States
facility: The Methodist
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: DePuy Synthes Mitek and Biomaterials
name: Jonathan B. McGlohorn
role: STUDY_DIRECTOR
References: