Restoration® Modular Revision Hip System Post Market Study
NCT ID: NCT00962013
Last Updated: 2017-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
137 participants
INTERVENTIONAL
2004-01-31
2011-12-31
Brief Summary
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Detailed Description
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In addition to demonstrating survivorship at 5 years, this study will seek to gain information on four secondary objectives: radiographic stability, Harris Hip Scores, SF-36 general well-being assessment, and safety profile.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Restoration® Modular
All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
Restoration® Modular Revision Hip System
Restoration® Modular Revision System
Interventions
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Restoration® Modular Revision Hip System
Restoration® Modular Revision System
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Patients who are severely immunocompromised.
* Patients who are prisoners.
18 Years
85 Years
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Barnett, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Specialty Institute
Michael W Britt, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Associates of Corpus Christi
Kenneth A Greene, MD
Role: PRINCIPAL_INVESTIGATOR
Crystal Clinic
Steven F Harwin, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Medical Center
D. Christopher Hikes, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Health & Services
Kirby Hitt, MD
Role: PRINCIPAL_INVESTIGATOR
Scott and White Hospital
William Hozack, md
Role: PRINCIPAL_INVESTIGATOR
Rothman Institute
Frederick Jaffe, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Joint Diseases
Timothy P Lovell, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Orthopaedic Specialties
Mark R Matthes, MD
Role: PRINCIPAL_INVESTIGATOR
Iowa Orthopaedic Center
Arthur Malkani, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish Hospital Center for Advanced Medicine
John Schurman, MD
Role: PRINCIPAL_INVESTIGATOR
Kansas Joint and Spine Institute
John Wright, MD
Role: PRINCIPAL_INVESTIGATOR
New West Sports Medicine and Orthopaedic Surgery
Locations
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Orthopaedic Specialty Institute
Orange, California, United States
Iowa Orthopaedic Center
Des Moines, Iowa, United States
Kansas Joint and Spine Institute
Wichita, Kansas, United States
Jewish Hospital Center for Advanced Medicine
Louisville, Kentucky, United States
New West Sports Medicine and Orthopaedic Surgery
Kearney, Nebraska, United States
Hospital for Joint Diseases
New York, New York, United States
Beth Israel Medical Center
New York, New York, United States
Crystal Clinic
Akron, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Orthopedic Associates of Corpus Christi
Corpus Christi, Texas, United States
Scott and White Hospital
Temple, Texas, United States
Providence Orthopaedic Specialities
Spokane, Washington, United States
Countries
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Other Identifiers
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53
Identifier Type: -
Identifier Source: org_study_id
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