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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01420237
First received: March 18, 2011
Last updated: February 19, 2016
Last verified: February 2016
  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: Restoration® Anatomic Dual Mobility (ADM) X3® Acetabular System Study With Long Term Data Collection for the Accolade® II Hip Stem

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Success Rate [ Time Frame: 10 years postoperative ] [ Designated as safety issue: Yes ]
    Defined as absence of postoperative femoral head dislocation.


Secondary Outcome Measures:
  • Harris Hip Score (HHS) score improvement from preoperative score [ Time Frame: pre-op, 6 week, 1,2,3,4,5 years ] [ Designated as safety issue: No ]
    The Harris Hip Score (HHS) assesses pain, function, joint deformity and range of motion. 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 of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor

  • All Cause Revision and Removal Rates of the Restoration ADM X3 Acetabular System [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Patient Satisfaction and Pain: Follow-up Questionnaire [ Time Frame: 6-10 years ] [ Designated as safety issue: No ]

    This questionnaire will be used to obtain the following information:

    • Satisfaction with the hip replacement
    • Presence of any pain in the study hip
    • Surgeries performed on the study hip
    • Any dislocations in the study hip

  • Radiographic Stability Rates [ Time Frame: 6 week,1,2,3,4,5 ] [ Designated as safety issue: Yes ]
    Cases that present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones will be considered radiographic failures.

  • Complication rates for Psoas Impingement and Associated Groin Pain [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Short Form-12 (SF-12) improvement from preoperative score [ Time Frame: preop, 6 week, 1,2,3,4,5 years ] [ Designated as safety issue: No ]
    The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

  • Lower Extremity Activity Scale (LEAS) improvement from preoperative score [ Time Frame: preop, 6 week, 1,2,3,4,5 years ] [ Designated as safety issue: No ]
    The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

  • EQ-5D Index Score improvement from preoperative score [ Time Frame: preop, 6 week, 1,2,3,4,5 years ] [ Designated as safety issue: No ]
    The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; the EQ visual analogue scale (EQ VAS) and EQ-5D descriptive system. The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively. The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems, where an overall score of 1 represents full health.

  • Percentage of cases which did not have any component revised [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: June 2011
Estimated Study Completion Date: June 2026
Estimated Primary Completion Date: June 2026 (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   (Adult, Senior)
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: Danielle Campbell 201-831-5498 danielle.campbell@stryker.com
Contact: Emily Valentino 201-831-5492 emily.valentino@stryker.com

Locations
United States, Arizona
Mezona Orthopedics Active, not recruiting
Gilbert, Arizona, United States, 85234
Arizona Institute for Bone and Joint Disorders Terminated
Phoenix, Arizona, United States, 85016
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Annie Phinizy    520-784-6141    aphinizy@tucsonortho.com   
Principal Investigator: Russell Cohen, MD         
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 Active, not recruiting
Sartell, Minnesota, United States, 56377
United States, Missouri
Missouri Orthopaedic Institute Recruiting
Columbia, Missouri, United States, 65212
Contact: J. Caleb Cheavens    573-882-7615    cheavensj@health.missouri.edu   
Principal Investigator: Ajay Aggarwal, MD         
United States, New York
Syracuse Orthopedic Specialists Active, not recruiting
Fatetteville, New York, United States, 13066
Hospital for Special Surgery Active, not recruiting
New York, New York, United States, 10021
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Johanna Dobransky    613-737-8899 ext 73032    jdobransky@ohri.ca   
Principal Investigator: Paul Kim, MD         
St. Michael's Hospital Active, not recruiting
Toronto, Ontario, Canada, M5B 1W8
Germany
Universitatsklinikum Madgeburg A.o.R. Orthopadische Universitatsklinikum Haus 8 Active, not recruiting
Madgeburg, Germany
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: 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, MD The Ottawa Hospital
Principal Investigator: James Waddell, MD St. Michael's Hospital, Toronto
Principal Investigator: Brett Greenky, MD Syracuse Orthopedic Specialists
Principal Investigator: Ajay Aggarwal, MD Missouri Orthopaedic Institute
Principal Investigator: Russell Cohen, MD Tucson Orthopaedic Institute
  More Information

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 19, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 27, 2016