Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01420237
First received: March 18, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the success rate of cementless primary hip replacement with the Restoration® ADM X3® Acetabular System as compared to other primary hip systems in the literature, through absence of femoral head dislocation at 10 years postoperative.


Condition Intervention
Arthroplasty, Replacement, Hip
Device: Restoration ADM X3 Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Study of the Restoration® ADM X3® Acetabular System

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Survival Rate [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
    To evaluate and determine the success rate, defined as absence of postoperative femoral head dislocation, at 10 years with the Restoration® ADM X3® Acetabular System. The number of patients with femoral head dislocations will be counted to calculate a Kaplan Meier Survival Curve for the device.


Secondary Outcome Measures:
  • Quality of Life Outcomes [ Time Frame: 10 years postoperative ] [ Designated as safety issue: No ]

    To compare function and health related quality of life (QOL) between the Restoration® ADM X3® Acetabular System and published results for other primary hip systems. The following outcomes measures will be used for this comparison: Harris Hip Score (HHS), Short Form-12 (SF-12), Lower Extremity Activity Scale (LEAS), EQ-5D.

    1-year, 2-year, 3-year, 4-year and 5-year HHS, SF-12 and LEAS will be compared to literature control with respect to improvement from preoperative scores. The EQ-5D data will be summarized and presented.


  • Functional Outcome [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
    To evaluate all-cause revision and removal rates in the Restoration® ADM X3® acetabular system and compare with those reported for other primary hip systems in the literature.


Estimated Enrollment: 350
Study Start Date: June 2011
Estimated Study Completion Date: August 2024
Estimated Primary Completion Date: August 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Restoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.
Device: Restoration ADM X3 Device
Restoration ADM X3 Device in total hip replacement.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has signed an IRB/EC approved, study specific Informed Patient Consent Form.
  • Patient is a male or non-pregnant female, skeletally mature and age 18-75 years at time of study device implantation.
  • Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
  • Patient is a candidate for a primary cementless acetabular replacement.
  • Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  • Patient has a Body Mass Index (BMI) ≥ 40.
  • Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
  • Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
  • Patient has a known sensitivity to device materials.
  • Patient is a prisoner.
  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: NCT01420237

Contacts
Contact: Carinna Kison 973-800-2744 carinna.kison@stryker.com
Contact: Danielle Anthony 201-831-5498 danielle.anthony@stryker.com

Locations
United States, Arizona
Mezona Orthopedics Recruiting
Gilbert, Arizona, United States, 85234
Contact: Leigh Breslauer    602-667-7965    lbreslauer@cox.net   
Principal Investigator: Kipling Sharpe, M.D.         
Arizona Institute for Bone and Joint Disorders Terminated
Phoenix, Arizona, United States, 85016
United States, Illinois
Rush University Medical Center Active, not recruiting
Chicago, Illinois, United States, 60612
United States, Michigan
Covenant Medical Center Active, not recruiting
Saginaw, Michigan, United States, 48602
United States, Minnesota
St. Cloud Orthopedic Associates Recruiting
Sartell, Minnesota, United States, 56377
Contact: Jerry Nelson, OPA-C    320-259-8044    jnelson@stcloudorthopedics.com   
Contact: Erik Hanson, PA    320-259-8044    ehanson@stcloudorthopedics.com   
Principal Investigator: Joseph Nessler, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: John Boles    212-774-7513    BolesJ@HSS.edu   
Principal Investigator: Geoffrey Westrich, M.D.         
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Peter Breithaupt    613-737-8920    pbreithaupt@ohri.ca   
Principal Investigator: Paul Kim, MD         
Germany
Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8 Recruiting
Madgeburg, Germany
Contact: Ivonne Rieback    +49 [0] 391 67-14004    ivonne.riebach@med.ovgu.de   
Principal Investigator: Christoph Lohmann, MD         
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Principal Investigator: Anthony Hedley, M.D. Arizona Institute for Bone & Joint Disorders
Principal Investigator: Kipling Sharpe, M.D. Mezona Orthopedics
Principal Investigator: Craig J. Della Valle, M.D. Rush University Medical Center
Principal Investigator: Geoffrey Westrich, M.D. Hospital for Special Surgery, New York
Principal Investigator: Douglas Padgett, M.D. Hospital for Special Surgery, New York
Principal Investigator: Joseph Nessler, M.D. St. Cloud Orthopedic Associates
Principal Investigator: Brian C de Beaubien, M.D. Covenant Medical Center
Principal Investigator: Christoph Lohmann, MD Universitatsklinikum Madgeburg A.o.R.
Principal Investigator: Paul Kim The Ottawa Hospital
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT01420237     History of Changes
Other Study ID Numbers: 70
Study First Received: March 18, 2011
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Stryker Orthopaedics:
Noninflammatory joint disease of the hip.

ClinicalTrials.gov processed this record on July 22, 2014