Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: August 14, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Arthroplasty, Replacement, 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: Yes ]
    Failure is defined by stem revision for any cause.

  • Femoral Stem Fracture [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Radiographic Stability [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.

  • Harris Hip Score [ Time Frame: pre-op and 5 years ] [ Designated as safety issue: No ]

    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


  • SF-36 Health Status Survey: Role - Physical [ Time Frame: pre-op, 2 year and 5 year ] [ Designated as safety issue: No ]

    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.


  • Post-surgery Femoral Crack/Fracture and Subsidence Rate [ Time Frame: Post-op to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 137
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
Restoration® Modular Revision System

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

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
Results First Received: April 4, 2014
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014