ORTHOVISC Shoulder RCT
Summary
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Glenohumeral Osteoarthritis
Intervention
ORTHOVISC
Location
CORE Orthopedics
Encinitas
California
United States
92024
Status
Active, not recruiting
Source
DePuy Mitek
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00436969
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Ketoprofen
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.
Viscosupplements
Viscoelastic solutions that are injected into JOINTS in order to alleviate symptoms of joint-related disorders such as OSTEOARTHRITIS.
Hallux Rigidus
A condition caused by degenerative arthritis (see OSTEOARTHRITIS) of the METATARSOPHALANGEAL JOINT of the great toe and characterized by pain and limited dorsiflexion, but relatively unrestricted plantar flexion.
Osteoarthritis, Hip
Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion.
Piroxicam
A cyclooxygenase inhibiting, non-steroidal anti-inflammatory agent (NSAID) that is well established in treating rheumatoid arthritis and osteoarthritis and used for musculoskeletal disorders, dysmenorrhea, and postoperative pain. Its long half-life enables it to be administered once daily.
Clinical Trials
Objective Evaluation of Shoulder Pathology and Surgery
The goal of this study was to clinically validate a new device for the objective outcome evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and rotato...
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.
Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion
Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by...
Cemented vs. Non-Cemented TSA for OA of the Shoulder
The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that...
Shoulder Proprioception Following Open and Arthroscopic Instability Repair
Shoulder dislocations are common and may result in functionally disabling instability. Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related to poor...
PubMed Articles
PURPOSE: Pigmented villonodular synovitis (PVNS) is a rare condition. Our purpose is to describe the largest series of patients with shoulder PVNS, massive irreparable rotator cuff tear, and glenohume...
Although the Bankart lesion is accepted as the primary pathology responsible for recurrent shoulder instability, recognition of other soft-tissue lesions has improved the surgical treatment for this c...
Detection and quantification of glenohumeral joint effusion: reliability of ultrasound.
OBJECTIVES: To evaluate reliability of ultrasound for detection and quantification of glenohumeral joint effusion. METHODS: With institutional review board approval and informed consent ultrasound of...
Arthroscopic options for regenerative treatment of cartilage defects in the shoulder.
Chondral or osteochondral lesions of the shoulder may lead to premature osteoarthritis of the glenohumeral joint as regeneration of damaged articular cartilage is lacking. Rising health awareness, inc...
