Recruiting

Ovation Hip System

Sponsor:

Ortho Development Corporation

Code:

NCT03986918

Conditions

Joint Diseases

Osteoarthritis, Hip

Rheumatoid Arthritis

Psoriatic Arthritis

Avascular Necrosis of Hip

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Routine Total Hip Arthroplasty

Study Details

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.

Conditions

Joint Diseases

Osteoarthritis, Hip

Rheumatoid Arthritis

Psoriatic Arthritis

Avascular Necrosis of Hip

Study ID

NCT03986918

Start date

Jun 1, 2019

Status verified date

Jun, 2019

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

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

Routine Total Hip Arthroplasty

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

Primary outcome measure

  • Survivorship - The number of revision surgeries over time. [ Time Frame: 5 - 10-year follow-up ]

Central Contacts and Locations

Central contacts

Samantha Andrews, PhD

8085224822samantha.andrews@straub.net

Locations

Straub Medical Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Samantha Andrews, PhD

808-522-4855samantha.andrews@straub.net

More Information

Sponsor

Ortho Development Corporation

Last update posted

Jun 14, 2019

Last verified

Jun, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ortho Development Corporation on 2019-06-14.