Not Signed In -
Shoulder Replacement |
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Clinical Trial: A Study of the Safety and Efficacy of Synvisc in Patients with Symptomatic Shoulder Osteoarthritis.
This study is no longer recruiting patients.
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Purpose
This clinical study is to evaluate the safety and efficacy of Synvisc in patients with symptomatic shoulder OA. Patients will be given Synvisc, with the possible administration of a second injection where insufficient symptomatic pain relief was experienced during the 3 months follow up period.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis of the shoulder Musculoskeletal | Device: Synvisc (hylan G-F 20) | Phase III |
MedlinePlus related topics: Osteoarthritis; Pain
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: Pain relief
Study start: April 2004; Study completion: September 2006
Last follow-up: February 2006; Data entry closure: April 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- patients with symptomatic OA pain of shoulder (gleno-humeral)
Exclusion Criteria:
- patients with current or prior conditions or treatment that would impede measurement of efficacy or safety
Location Information
France
Clinique Saint Anne Lumiere, Lyon, 69003, France
CHRU Hopital Trousseau, Tours, 37044, France
Hopital Ambroise Pare, Boulogne-Billancourt, 92100, France
Centre de Medecine et Traumatologie du Sport Clinique du Sport, Merignac, 33700, France
Germany
August-Viktoria-Klinik, Bad Oeynhausen, 32545, Germany
Universitatsklinik und Poliklinik Orthopadie & Physikalische Medizin, Halle/Saale, 06097, Germany
Study chairs or principal investigators
David Perkins, Study Director, Genzyme
More Information
Study ID Numbers: SYNV-002-01
Last Updated: August 17, 2005
Record first received: August 17, 2005
ClinicalTrials.gov Identifier: NCT00131300
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 17, 2005
Record first received: August 17, 2005
ClinicalTrials.gov Identifier: NCT00131300
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Joint Replacement (Cleveland Clinic)
- Reverse Shoulder Repair (Cleveland Clinic)
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