Restoration® Modular Revision Hip System Post Market Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00962013
First received: August 13, 2009
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Arthropathy of Hip
Device: Restoration Modular Revision Hip System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Open-Label Evaluation of the Restoration Modular System

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Stem Survivorship [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    This study will demonstrate the 5- year survivorship is approximately 95% by demonstrating that the observed rate is not 7% worse than 95% in other words at or above 88% using a one-sided 95% confidence bound. Failure is defined by stem revision for any cause.


Secondary Outcome Measures:
  • Radiographic Stability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Radiographic stability - a low deterioration rate in bone stock as measured by radiographic parameters (radiolucent lines, progressive stem migration, and subsidence) established by Hip Society.

  • Pain and Function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Relieve pain and improve function - compare Harris Hip Score to pre-revision. The mean HHS for the population should be greater than or equal to 75 points at the 5-year evaluation and show an improvement relative to pre-operative scores.

  • Patient Satisfaction [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Evaluate patient satisfaction - Physical role function vector scores on SF-36 should improve significantly over the 5-year evaluation period as compared to the pre-revision scores.

  • Adverse Events [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
    Evaluate patient satisfaction - Physical role function vector scores on SF-36 should improve significantly over the 5-year evaluation period as compared to the pre-revision scores.


Enrollment: 144
Study Start Date: January 2004
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Restoration Modular
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
To determine the survivorship of the femoral stem as compared to the historical control population.

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 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962013

Locations
United States, California
Orthopaedic Specialty Institute
Orange, California, United States, 92868
United States, Iowa
Iowa Orthopaedic Center
Des Moines, Iowa, United States, 50314
United States, Kansas
Kansas Joint and Spine Institute
Wichita, Kansas, United States, 67226
United States, Kentucky
Jewish Hospital Center for Advanced Medicine
Louisville, Kentucky, United States, 40202
United States, Nebraska
New West Sports Medicine and Orthopaedic Surgery
Kearney, Nebraska, United States, 68847
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10021
Hospital for Joint Diseases
New York, New York, United States, 10003
United States, Ohio
Crystal Clinic
Akron, Ohio, United States, 44333
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Orthopedic Associates of Corpus Christi
Corpus Christi, Texas, United States, 78411
Scott and White Hospital
Temple, Texas, United States, 76508
United States, Washington
Providence Orthopaedic Specialities
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Principal Investigator: Steven Barnett, MD Orthopaedic Specialty Institute
Principal Investigator: Michael W Britt, MD Orthopaedic Associates of Corpus Christi
Principal Investigator: Kenneth A Greene, MD Crystal Clinic
Principal Investigator: Steven F Harwin, MD Beth Israel Medical Center
Principal Investigator: D. Christopher Hikes, MD Providence Health & Services
Principal Investigator: Kirby Hitt, MD Scott and White Hospital
Principal Investigator: William Hozack, md Rothman Institute
Principal Investigator: Frederick Jaffe, MD Hospital for Joint Diseases
Principal Investigator: Timothy P Lovell, MD Providence Orthopaedic Specialties
Principal Investigator: Mark R Matthes, MD Iowa Orthopaedic Center
Principal Investigator: Arthur Malkani, MD Jewish Hospital Center for Advanced Medicine
Principal Investigator: John Schurman, MD Kansas Joint and Spine Institute
Principal Investigator: John Wright, MD New West Sports Medicine and Orthopaedic Surgery
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00962013     History of Changes
Other Study ID Numbers: 53
Study First Received: August 13, 2009
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014