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Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System

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ClinicalTrials.gov Identifier: NCT03986918
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ortho Development Corporation

Brief Summary:
The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.

Condition or disease Intervention/treatment
Joint Diseases Osteoarthritis, Hip Rheumatoid Arthritis Psoriatic Arthritis Avascular Necrosis of Hip Device: Routine Total Hip Arthroplasty

Detailed Description:

Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.

This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2024


Group/Cohort Intervention/treatment
Ovation and Ovation Tribute
All patients having undergone a total hip arthroplasty that received the Ovation® or Ovation Tribute® (Ortho Development, Draper, Utah) Hip system will be sent the survey.
Device: Routine Total Hip Arthroplasty
Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.




Primary Outcome Measures :
  1. Survivorship - The number of revision surgeries over time. [ Time Frame: 5 - 10-year follow-up ]
    The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.


Secondary Outcome Measures :
  1. Pain and Function [ Time Frame: 5 - 10 year follow-up ]
    The Hip Disability and Osteoarthritis Outcome score - joint replacement (HOOS JR) will be used. The HOOS-JR is a joint replacement survey designed to measure pain and function.

  2. General Health [ Time Frame: 5 - 10 year follow-up ]
    The Veterans Rand - 12 (VR-12) will be used to measure general health, including the ability to carry out usual activities.

  3. Patient satisfaction. [ Time Frame: 5 - 10 year follow-up ]
    A four question patient satisfaction survey will be used to measure the patient's satisfaction with their surgery, pain control, function, and ability to participate in recreational activities.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Identification will occur from a list of patients having undergone total hip arthroplasty at Straub Medical Center between 2012 and the end of December 2015. Identified patients will then be screened for eligibility criteria
Criteria

Inclusion Criteria:

  • Patient is at least 18 years of age
  • Patient is five years post total hip arthroplasty
  • Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
  • Patient agrees to participate in the survey.

Exclusion Criteria:

  • Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986918


Contacts
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Contact: Samantha Andrews, PhD 8085224822 samantha.andrews@straub.net

Locations
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United States, Hawaii
Straub Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Samantha Andrews, PhD    808-522-4855    samantha.andrews@straub.net   
Sponsors and Collaborators
Ortho Development Corporation
Investigators
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Principal Investigator: Cass Nakasone, MD Hawai'i Pacific Health

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Responsible Party: Ortho Development Corporation
ClinicalTrials.gov Identifier: NCT03986918     History of Changes
Other Study ID Numbers: P-17-0013B
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Osteoarthritis
Necrosis
Joint Diseases
Osteoarthritis, Hip
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases