A Prospective Clinical Study On A Total Hip Resurfacing System
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis; Avascular Necrosis
Intervention: ReCap Total Hip Resurfacing System (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
H P Delport, MD, Principal Investigator, Affiliation: AZ NIKOLAAS CAMPUS SINT NIKLAAS
Jo De Schepper, MD, Principal Investigator, Affiliation: AZ NIKOLAAS CAMPUS SINT NIKLAAS
Overall contact:
Johan DeWitte, Phone: 32-475414009, Email: johan.Dewitte@biometeurope.com
Summary
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip
Resurfacing System.
Clinical Details
Official title: A Prospective Clinical Study On A Total Hip Resurfacing System
Study design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Secondary outcome: Complications
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- intended for skeletally mature individuals undergoing primary surgery as a result of
hip degenerative joint disease, or any composite diagnoses, including:
- Osteoarthritis
- Avascular necrosis
- Traumatic arthritis
- Legg Perthes
- Rheumatoid arthritis
Locations and Contacts
Johan DeWitte, Phone: 32-475414009, Email: johan.Dewitte@biometeurope.com
Az Nikolaas Campus Sint Niklaas, Sint Niklaas, Belgium; Recruiting
Johan DeWitte, Phone: 32-475414009, Email: johan.dewitte@biometeurope.com
Additional Information
Starting date: October 2004
Ending date: October 2017
Last updated: September 26, 2008
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