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Clinical Trials in the USA / NCT04277416
Enrolling by invitation Observational

Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty

NCT04277416 · tracked via the Priya Life Science USA tracker
Sponsor
Ortho Development Corporation
Phase
Observational
Started
2020-02-28
Last updated
2022-10-13

Condition(s) studied

Total Hip ReplacementTotal Hip Arthroplasty

Investigational drug(s) / intervention(s)

Total Hip Arthroplasty

Total Hip Arthroplasty: To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 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 Criteria: The potential participant should be excluded from enrollment if any of the following exist: 1. Body mass index ≥ 40 2. 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 3. History of pyogenic arthritis in the surgical hip joint 4. Active or suspected infection in or around the surgical hip joint 5. A neurological disorder that, in the investigator's opinion, could affect lower extremity function and recovery from the index THA 6. The potential participant is incarcerated 7. Prior fusion to the index surgical hip joint 8. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Oregon Health Sciences University Portland Oregon

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04277416 on ClinicalTrials.gov ↗ ← All trials in the USA