Restoration® Modular Revision Hip System Post Market Study

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate survivorship of the femoral stem at 5 years.

Detailed Description
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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 proximal 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.

Official Title
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A Prospective Open-Label Evaluation of the Restoration® Modular System

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Restoration® Modular Revision Hip System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Restoration® Modular<br>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<br>* Restoration® Modular Revision System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem Survivorship (%) | Failure is defined by stem revision for any cause. | 5 years | 
| Femoral Stem Fracture |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Stability | Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view. | 5 years | 
| Harris Hip Score | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor | pre-op and 5 years | 
| SF-36 Health Status Survey: Role - Physical | Consists of 8 subscores all with a range of 0-100; a higher score indicates a better health state: The subscores are: 1 - Physical Functioning, 2 - Role-Physical, 3 - Bodily Pain, 4 - General Health, 5 - Vitality, 6 - Social Functioning, 7- Role-Emotional, 8 - Mental Health This Secondary Outcome Measure is focused on the Role-Physical score. | pre-op, 2 year and 5 year | 
| Post-surgery Femoral Crack/Fracture and Subsidence Rate |  | Post-op to 5 years |