Restoration® Modular Revision Hip System Post Market Study
This study has been completed.
Sponsor:
Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00962013
First received: August 13, 2009
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.
| Condition | Intervention |
|---|---|
|
Arthropathy of Hip |
Device: Restoration Modular Revision Hip System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Open-Label Evaluation of the Restoration Modular System |
Resource links provided by NLM:
Further study details as provided by Stryker Orthopaedics:
Primary Outcome Measures:
- Stem Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: No ]This study will demonstrate the 5- year survivorship is approximately 95% by demonstrating that the observed rate is not 7% worse than 95% in other words at or above 88% using a one-sided 95% confidence bound. Failure is defined by stem revision for any cause.
Secondary Outcome Measures:
- Radiographic Stability [ Time Frame: 5 years ] [ Designated as safety issue: No ]Radiographic stability - a low deterioration rate in bone stock as measured by radiographic parameters (radiolucent lines, progressive stem migration, and subsidence) established by Hip Society.
- Pain and Function [ Time Frame: 5 years ] [ Designated as safety issue: No ]Relieve pain and improve function - compare Harris Hip Score to pre-revision. The mean HHS for the population should be greater than or equal to 75 points at the 5-year evaluation and show an improvement relative to pre-operative scores.
- Patient Satisfaction [ Time Frame: 5 year ] [ Designated as safety issue: No ]Evaluate patient satisfaction - Physical role function vector scores on SF-36 should improve significantly over the 5-year evaluation period as compared to the pre-revision scores.
- Adverse Events [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]Evaluate patient satisfaction - Physical role function vector scores on SF-36 should improve significantly over the 5-year evaluation period as compared to the pre-revision scores.
| Enrollment: | 144 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Device: Restoration Modular Revision Hip System
To determine the survivorship of the femoral stem as compared to the historical control population.
|
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 System in revision cases only. The stems are intended to be used with Stryker Orthopaedics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the femur.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- Patients with ongoing infection.
- Patients who are severely immunocompromised.
- Patients who are prisoners.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00962013
Locations
| United States, California | |
| Orthopaedic Specialty Institute | |
| Orange, California, United States, 92868 | |
| United States, Iowa | |
| Iowa Orthopaedic Center | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Kansas | |
| Kansas Joint and Spine Institute | |
| Wichita, Kansas, United States, 67226 | |
| United States, Kentucky | |
| Jewish Hospital Center for Advanced Medicine | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Nebraska | |
| New West Sports Medicine and Orthopaedic Surgery | |
| Kearney, Nebraska, United States, 68847 | |
| United States, New York | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10021 | |
| Hospital for Joint Diseases | |
| New York, New York, United States, 10003 | |
| United States, Ohio | |
| Crystal Clinic | |
| Akron, Ohio, United States, 44333 | |
| United States, Oregon | |
| Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Rothman Institute | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Texas | |
| Orthopedic Associates of Corpus Christi | |
| Corpus Christi, Texas, United States, 78411 | |
| Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| United States, Washington | |
| Providence Orthopaedic Specialities | |
| Spokane, Washington, United States, 99204 | |
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
| Principal Investigator: | Steven Barnett, MD | Orthopaedic Specialty Institute |
| Principal Investigator: | Michael W Britt, MD | Orthopaedic Associates of Corpus Christi |
| Principal Investigator: | Kenneth A Greene, MD | Crystal Clinic |
| Principal Investigator: | Steven F Harwin, MD | Beth Israel Medical Center |
| Principal Investigator: | D. Christopher Hikes, MD | Providence Health & Services |
| Principal Investigator: | Kirby Hitt, MD | Scott and White Hospital |
| Principal Investigator: | William Hozack, md | Rothman Institute |
| Principal Investigator: | Frederick Jaffe, MD | Hospital for Joint Diseases |
| Principal Investigator: | Timothy P Lovell, MD | Providence Orthopaedic Specialties |
| Principal Investigator: | Mark R Matthes, MD | Iowa Orthopaedic Center |
| Principal Investigator: | Arthur Malkani, MD | Jewish Hospital Center for Advanced Medicine |
| Principal Investigator: | John Schurman, MD | Kansas Joint and Spine Institute |
| Principal Investigator: | John Wright, MD | New West Sports Medicine and Orthopaedic Surgery |
More Information
No publications provided
| Responsible Party: | Stryker Orthopaedics |
| ClinicalTrials.gov Identifier: | NCT00962013 History of Changes |
| Other Study ID Numbers: | 53 |
| Study First Received: | August 13, 2009 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013