ORTHOVISC Shoulder RCT (OV Shoulder)
This study has been completed.
Sponsor:
DePuy Mitek
Information provided by (Responsible Party):
DePuy Mitek
ClinicalTrials.gov Identifier:
NCT00436969
First received: February 16, 2007
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Glenohumeral Osteoarthritis |
Device: Orthovisc Drug: Celestone (betamethasone sodium phosphate and acetate) - 2 mL Drug: Marcaine (bupivacaine) - 6 mL |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial |
Resource links provided by NLM:
Drug Information available for:
Betamethasone sodium phosphate
Betamethasone
Betamethasone valerate
Betamethasone dipropionate
Sodium phosphate
Hyaluronic Acid
Hyaluronate Sodium
Sodium phosphate, dibasic
Bupivacaine hydrochloride
Bupivacaine
U.S. FDA Resources
Further study details as provided by DePuy Mitek:
Primary Outcome Measures:
- VAS Pain score [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
| Enrollment: | 270 |
| Study Start Date: | December 2006 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Injection with corticosteroid/anesthetic
Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8mL's).
|
Drug: Celestone (betamethasone sodium phosphate and acetate) - 2 mL Drug: Marcaine (bupivacaine) - 6 mL |
|
Experimental: Injection with Orthovisc
Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.
|
Device: Orthovisc
Orthovisc injection
|
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| Ages Eligible for Study: | 25 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436969
Locations
| United States, California | |
| CORE Orthopedics | |
| Encinitas, California, United States, 92024 | |
| Sierra Pacific Orthopaedic Center Medical Group | |
| Fresno, California, United States, 93720 | |
| United States, Florida | |
| UHZ Sports Medicine | |
| Coral Gables, Florida, United States, 33146 | |
| Andrews Research Institute | |
| Gulf Breeze, Florida, United States, 32561 | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Massachusetts | |
| University of Massachusetts Merdical School - Worcester | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Shores Rheumatology | |
| St Clair Shores, Michigan, United States, 48081 | |
| United States, New York | |
| Insall Scott Kelly Institute | |
| New York, New York, United States, 10065 | |
| United States, Oklahoma | |
| Tulsa Bone and Joint | |
| Tulsa, Oklahoma, United States, 74146 | |
| United States, Pennsylvania | |
| University Orthopedics Center | |
| State College, Pennsylvania, United States, 16801 | |
| United States, Texas | |
| The Methodist | |
| Houston, Texas, United States, 11030 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| United States, Washington | |
| Madigan Army Medical Center | |
| Tacoma, Washington, United States, 98431 | |
Sponsors and Collaborators
DePuy Mitek
More Information
No publications provided
| Responsible Party: | DePuy Mitek |
| ClinicalTrials.gov Identifier: | NCT00436969 History of Changes |
| Other Study ID Numbers: | 06-OV-01 |
| Study First Received: | February 16, 2007 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by DePuy Mitek:
|
Orthovisc Osteoarthritis Shoulder Randomized |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Anesthetics Bupivacaine Betamethasone-17,21-dipropionate Betamethasone Betamethasone sodium phosphate Hyaluronic Acid Sodium phosphate Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents Adjuvants, Immunologic Immunologic Factors Cathartics Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013