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Enrolling by Invitation

NCT Number: NCT04277416

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

Enrolling by Invitation

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Key information

Conditions

Total Hip Replacement Total Hip Arthroplasty

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Treatment and study plan

Total hip arthroplasty

Device

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 outcomes

  1. Implant Survival

    Time frame: 5 - 10-year follow-up

    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.

Secondary outcomes

  1. Implant Survival

    Time frame: 2 - 10 year follow-up

    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. Hip Disability and Osteoarthritis Outcome Score for Joint Reconstruction (HOOS JR)

    Time frame: 2 - 10-year follow-up

    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.

  3. PROMIS Global Health Assessment (Physical health, mental health and numeric pain score)

    Time frame: 2 - 10-year follow-up

    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.

  4. UCLA Activity Rating Scale

    Time frame: 2 - 10-year follow-up

    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.

  5. Patient Satisfaction

    Time frame: 2 - 10-year follow-up

    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.

  6. Radiographic Outcomes

    Time frame: 2 - 10-year follow-up

    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.

  7. Clinical Outcomes

    Time frame: 2 - 10-year follow-up

    Clinical adverse events: Adverse events will be captured on the adverse event case report form.

  8. Patient Satisfaction

    Time frame: 2 - 10-year follow-up

    Satisfaction with the surgical intervention according to the PROMIS Global 10 methods of Rolfson et al.

Sponsors and collaborators

Lead sponsor

Ortho Development Corporation

Industry

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2031
Study completion
2032
First posted
Feb 20, 2020
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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