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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03986918
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ortho Development Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Cass Nakasone, MD
Principal Investigator Affiliation Hawai'i Pacific Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Joint Diseases, Osteoarthritis, Hip, Rheumatoid Arthritis, Psoriatic Arthritis, Avascular Necrosis of Hip
Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Device: - Routine Total Hip Arthroplasty

Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Straub Medical Center, Honolulu, Hawaii

Status

Recruiting

Address

Straub Medical Center

Honolulu, Hawaii, 96813

Site Contact

Samantha Andrews, PhD

[email protected]

808-522-4855