Restoration® Modular Revision Hip System Post Market Study

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: Restoration® Modular Revision Hip System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00962013

53

Details and patient eligibility

About

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

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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137 participants in 1 patient group

Restoration® Modular

Other group

Description:

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.

Treatment:

Device: Restoration® Modular Revision Hip System