Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Hip Arthroplasty.
- Who it may be relevant to
- Registry conditions: Total Hip Replacement, Total Hip Arthroplasty. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty: A Prospective Multi-Centre Cohort Study
Overview
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 introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners.
Interventions
- Device 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.
Primary outcome measures
- Implant Survival [Time frame: 5 - 10-year follow-up]
Secondary outcome measures (8)
- Implant Survival [Time frame: 2 - 10 year follow-up]
- Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR) [Time frame: 2 - 10-year follow-up]
- PROMIS Global Health Assessment (Physical health, mental health and numeric pain score) [Time frame: 2 - 10-year follow-up]
- UCLA Activity Rating Scale [Time frame: 2 - 10-year follow-up]
- Patient Satisfaction [Time frame: 2 - 10-year follow-up]
- Radiographic Outcomes [Time frame: 2 - 10-year follow-up]
- Clinical Outcomes [Time frame: 2 - 10-year follow-up]
- Patient Satisfaction [Time frame: 2 - 10-year follow-up]
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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Oregon Health Sciences University — Portland
Identifiers
NCT: NCT04277416 · P-19-0055