Clinical trial NCT00962013: Restoration® Modular Revision Hip System Post Market Study
Official title: A Prospective Open-Label Evaluation of the Restoration® Modular System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Eligibility 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.

Primary outcomes:
measure: Stem Survivorship (%)
timeFrame: 5 years
measure: Femoral Stem Fracture
timeFrame: 5 years
Secondary outcomes:
measure: Radiographic Stability
timeFrame: 5 years
measure: Harris Hip Score
timeFrame: pre-op and 5 years
measure: SF-36 Health Status Survey: Role - Physical
timeFrame: pre-op, 2 year and 5 year
measure: Post-surgery Femoral Crack/Fracture and Subsidence Rate
timeFrame: Post-op to 5 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Des Moines
country: United States
facility: Iowa Orthopaedic Center
state: Iowa
city: Wichita
country: United States
facility: Kansas Joint and Spine Institute
state: Kansas
city: Louisville
country: United States
facility: Jewish Hospital Center for Advanced Medicine
state: Kentucky
city: Kearney
country: United States
facility: New West Sports Medicine and Orthopaedic Surgery
state: Nebraska
city: New York
country: United States
facility: Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Akron
country: United States
facility: Crystal Clinic
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Corpus Christi
country: United States
facility: Orthopedic Associates of Corpus Christi
state: Texas
city: Temple
country: United States
facility: Scott and White Hospital
state: Texas
city: Spokane
country: United States
facility: Providence Orthopaedic Specialities
state: Washington
Study officials:
affiliation: Orthopaedic Specialty Institute
name: Steven Barnett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedic Associates of Corpus Christi
name: Michael W Britt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Crystal Clinic
name: Kenneth A Greene, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Medical Center
name: Steven F Harwin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Health & Services
name: D. Christopher Hikes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott and White Hospital
name: Kirby Hitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rothman Institute
name: William Hozack, md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Joint Diseases
name: Frederick Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Providence Orthopaedic Specialties
name: Timothy P Lovell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa Orthopaedic Center
name: Mark R Matthes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jewish Hospital Center for Advanced Medicine
name: Arthur Malkani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansas Joint and Spine Institute
name: John Schurman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New West Sports Medicine and Orthopaedic Surgery
name: John Wright, MD
role: PRINCIPAL_INVESTIGATOR
References: