Status:
COMPLETED
Restoration® Modular Revision Hip System Post Market Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
Detailed Description
The two-piece modular revision stem components are intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. This study evaluates the...
Eligibility Criteria
Inclusion
- Candidates for cementless revision of a failed femoral prosthesis.
- Patients willing to sign the informed consent.
- Patients able to comply with follow-up requirements including post-operative weightbearing restrictions and self-evaluations.
- Male and non-pregnant female patients ages 18 to 85 years of age at the time of surgery.
Exclusion
- Patients with ongoing infection.
- Patients who are severely immunocompromised.
- Patients who are prisoners.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00962013
Start Date
January 1 2004
End Date
December 1 2011
Last Update
March 29 2017
Active Locations (13)
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1
Orthopaedic Specialty Institute
Orange, California, United States, 92868
2
Iowa Orthopaedic Center
Des Moines, Iowa, United States, 50314
3
Kansas Joint and Spine Institute
Wichita, Kansas, United States, 67226
4
Jewish Hospital Center for Advanced Medicine
Louisville, Kentucky, United States, 40202