Status:
ENROLLING_BY_INVITATION
Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty
Lead Sponsor:
Ortho Development Corporation
Collaborating Sponsors:
Oregon Health and Science University
Conditions:
Total Hip Replacement
Total Hip Arthroplasty
Eligibility:
All Genders
18-80 years
Brief Summary
To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
Detailed Description
The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introdu...
Eligibility Criteria
Inclusion
- 1\. Scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip 2. System due to at least one of the following indications:
- Osteoarthritis
- Inflammatory arthropathy (Rheumatoid Arthritis, Psoriatic Arthritis, etc.) with sufficient bone stock for standard primary THA implants
- Avascular Necrosis with sufficient bone stock for standard primary THA implants
- Post-traumatic Arthritis
- Secondary arthritis due to congenital hip dysplasia 3. Willing and able to provide written informed consent for participation in the study.
- 4\. Aged 18 - 80 years. 5. Able (in the Investigators opinion) and willing to comply with all study requirements and complete all study visits
Exclusion
- The potential participant should be excluded from enrollment if any of the following exist:
- Body mass index ≥ 40
- History of other orthopaedic surgery within 6 months prior to the index surgery that, in the investigator's opinion, could affect the recovery of the index THA
- History of pyogenic arthritis in the surgical hip joint
- Active or suspected infection in or around the surgical hip joint
- A neurological disorder that, in the investigator's opinion, could affect lower extremity function and recovery from the index THA
- The potential participant is incarcerated
- Prior fusion to the index surgical hip joint
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- 9 . Any other contraindication to THA listed in the Entrada™ Hip Stem Labelling or Instructions for Use.
Key Trial Info
Start Date :
February 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04277416
Start Date
February 28 2020
End Date
December 31 2032
Last Update
October 13 2022
Active Locations (1)
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1
Oregon Health Sciences University
Portland, Oregon, United States, 97239