Restoration® Modular Revision Hip System Post Market Study

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

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Restoration® Modular Revision Hip 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.

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Orthopaedic Specialty Institute
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Orthopaedic Center
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Kansas Joint and Spine Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital Center for Advanced Medicine
  • Nebraska
    • Kearney, Nebraska, United States, 68847
      • New West Sports Medicine and Orthopaedic Surgery
  • New York
    • New York, New York, United States, 10003
      • Hospital for Joint Diseases
    • New York, New York, United States, 10021
      • Beth Israel Medical Center
  • Ohio
    • Akron, Ohio, United States, 44333
      • Crystal Clinic
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • Orthopedic Associates of Corpus Christi
    • Temple, Texas, United States, 76508
      • Scott and White Hospital
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Orthopaedic Specialities

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stem Survivorship (%)	Failure is defined by stem revision for any cause.	5 years
Femoral Stem Fracture		5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Stability	Absence of a radiolucent lines ≥ 2mm around the entire stem in AP or ML view.	5 years
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
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
Post-surgery Femoral Crack/Fracture and Subsidence Rate		Post-op to 5 years

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 13, 2009
• First Submitted That Met QC Criteria: August 17, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 10, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 53