Restoration® Modular Revision Hip System Post Market Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962013
• Other study ID #: 53
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: August 14, 2014
• Start date: January 2004
• Est. completion date: December 2011

Study information

• Verified date: August 2014
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Restoration® Modular Revision Hip System
Restoration® Modular Revision System

Locations

Country	Name	City	State
United States	Crystal Clinic	Akron	Ohio
United States	Orthopedic Associates of Corpus Christi	Corpus Christi	Texas
United States	Iowa Orthopaedic Center	Des Moines	Iowa
United States	New West Sports Medicine and Orthopaedic Surgery	Kearney	Nebraska
United States	Jewish Hospital Center for Advanced Medicine	Louisville	Kentucky
United States	Beth Israel Medical Center	New York	New York
United States	Hospital for Joint Diseases	New York	New York
United States	Orthopaedic Specialty Institute	Orange	California
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Providence Orthopaedic Specialities	Spokane	Washington
United States	Scott and White Hospital	Temple	Texas
United States	Kansas Joint and Spine Institute	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stem Survivorship (%)	Failure is defined by stem revision for any cause.	5 years	Yes
Primary	Femoral Stem Fracture		5 years	Yes
Secondary	Radiographic Stability	Absence of a radiolucent lines = 2mm around the entire stem in AP or ML view.	5 years	Yes
Secondary	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	No
Secondary	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	No
Secondary	Post-surgery Femoral Crack/Fracture and Subsidence Rate		Post-op to 5 years	Yes