Restoration® Modular Revision Hip System Post Market Study

N/ACompletedNCT00962013

Stryker Orthopaedics137 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

137

Conditions

Arthroplasty, Replacement, Hip

Interventions

Restoration® Modular Revision Hip SystemDEVICE

Restoration® Modular Revision System

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (13)

Orthopaedic Specialty Institute

Orange, California, United States

Iowa Orthopaedic Center

Des Moines, Iowa, United States

Kansas Joint and Spine Institute

Wichita, Kansas, United States

Outcomes

Primary Outcomes

Stem Survivorship (%)

Failure is defined by stem revision for any cause.

Time frame: 5 years

Femoral Stem Fracture

Time frame: 5 years

Secondary Outcomes

Radiographic Stability

Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.

Time frame: 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

Time frame: 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.

Time frame: pre-op, 2 year and 5 year

Post-surgery Femoral Crack/Fracture and Subsidence Rate

Time frame: Post-op to 5 years

Data from ClinicalTrials.gov

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