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

Launched by ORTHO DEVELOPMENT CORPORATION · Feb 17, 2020

Keywords

ClinConnect Summary

This is an observational, prospective group study (a real-world look) to evaluate how well the Entrada Hip System works in people having a first-time total hip replacement. It aims to follow about 250 adults who are getting the Entrada Hip System at multiple centers in the United States, including Oregon Health & Science University. The study began around 2020 and is currently enrolling by invitation, with results planned through about 2032. The main question is whether the hip implant lasts without needing to be removed, looked at over roughly 5 years (and up to 10 years in some analyses).

Participants will have follow‑ups at about 1, 2, 5, and 10 years after surgery. They will complete questionnaires about hip function, pain, general health, activity, and satisfaction, and doctors will check X‑rays for any problems. The study will also record any adverse events. In addition to the primary goal of implant survival at 5 years, researchers will analyze survival at 2 and 10 years, as well as changes in hip function and quality of life, patient satisfaction, and any radiographic or clinical complications. Eligible participants are adults aged 18–80 scheduled for primary THA with the Entrada Hip System; major exclusions include BMI of 40 or higher, recent other hip surgery, active infection, certain other medical conditions, or contraindications to hip replacement as listed in the study criteria. The study is sponsored by Ortho Development Corporation, with Oregon Health & Science University collaborating, and does not share individual participant data.

Gender

ALL

Eligibility criteria

• 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.