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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Survivorship and Effectiveness of the Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty: A Prospective Multi-Centre Cohort Study

Conditions
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Total Hip Replacement, Total Hip Arthroplasty

Intervention / Treatment
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* Device: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Entrada Hip System<br>All orthopaedic patients that are scheduled to undergo primary total hip arthroplasty using the Entrada™ Hip System within 12 weeks will be screened for the following eligibility criteria. | Device: Total Hip Arthroplasty<br>* To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival | Implant survival based on removal or intended removal of any component of Entrada Hip Sys @five years follow-up. Will be measured using the Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction, the Patient-Reported Outcomes Measurement Information System Global Health Assessment, the UCLA Activity Rating Scale. Effectiveness will be assessed by achieving minimal clinically important difference (MCID) in HOOS JR and UCLA Activity scores. Hung et al. recently reported MCID of HOOS JR to be 19.68 units in an adult recon pop. The MCID for UCLA activity score has been reported to be 0.92 units.minimal detectable change for the PROMIS Global physical and mental health measures will be assessed using one-half of the standard dev between the pre and last post change score. MCID for numeric pain scale will be assessed as a 2 unit change in pain. HOOS, JR score ranges from 1-100 where 0 = total hip disability 100 = perfect hip health. | 5 - 10-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival | Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at two and ten years of follow-up. Will be measured using the Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR), the PROMIS Global Health Assessment (Physical health, mental health and Numeric pain score), and the UCLA Activity Rating Scale. | 2 - 10 year follow-up | 
| Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR) | The HOOS JR patient reported outcome instrument will be assessed at one, two, five and ten years. The HOOS JR measures function and pain in the involved hip. | 2 - 10-year follow-up | 
| PROMIS Global Health Assessment (Physical health, mental health and numeric pain score) | The PROMIS Global 10 patient reported outcome instrument will be assessed at one, two, five and ten years. The PROMIS Global 10 measures physical health, mental health and provides an 11 point numeric pain score. | 2 - 10-year follow-up | 
| UCLA Activity Rating Scale | The UCLA patient reported outcome instrument will be assessed at one, two, five and ten years. The scale is from 1 - 10 with higher values indicating greater physical function. | 2 - 10-year follow-up | 
| Patient Satisfaction | Patient Satisfaction with their hip replacement will be assessed at one, two, five and ten years. Satisfaction will be measured on a 5 point likert scale from very unsatisfied to very satisfied. | 2 - 10-year follow-up | 
| Radiographic Outcomes | Radiographic adverse events: Adverse events will be captured on the adverse event case report form. Radiographic adverse events will be evaluated using the zones for radiolucencies as described on the radiographic evaluation case report form. These include the femoral zones described by Gruen et al. Radiolucent lines <2mm will be considered fibrous integration as per the review of Vanrusselt et al. Without evidence of progression these lines will not be considered evidence of aseptic loosening. | 2 - 10-year follow-up | 
| Clinical Outcomes | Clinical adverse events: Adverse events will be captured on the adverse event case report form. | 2 - 10-year follow-up | 
| Patient Satisfaction | Satisfaction with the surgical intervention according to the PROMIS Global 10 methods of Rolfson et al. | 2 - 10-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ortho Development, Entrada Hip System