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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04277416
• Other study ID #: P-19-0055
• Status: Enrolling by invitation
• Start date: February 28, 2020
• Est. completion date: December 31, 2032

Study information

• Verified date: October 2022
• Source: Ortho Development Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Hip Arthroplasty
• Total Hip Replacement

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Health Sciences University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Ortho Development Corporation	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Clinical Outcomes	Clinical adverse events: Adverse events will be captured on the adverse event case report form.	2 - 10-year follow-up
Secondary	Patient Satisfaction	Satisfaction with the surgical intervention according to the PROMIS Global 10 methods of Rolfson et al.	2 - 10-year follow-up