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Ortho Development® Entrada™ Hip System for Total Hip Arthroplasty

This study is looking at how well the Ortho Development® Entrada™ Hip System works for people having a total hip replacement (arthroplasty). Researchers want to see how long the implant (the new hip parts) lasts before any part needs to be removed or is planned to be removed. You might be able to join if you are between 18 and 80 years old and are scheduled to have a total hip replacement using the Entrada™ Hip System because of conditions like osteoarthritis or rheumatoid arthritis. The study aims to follow participants for 5 to 10 years to understand the implant's survival. The current status of this study is unclear, and it plans to enroll about 250 people.

Study design
This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It plans to include about 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 to 10 years to check the implant's survival.

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NCT04277416

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

Enrolling by Invitation
Not specifiedAges 18–80Observational
Ortho Development Corporation
~250 participants
Updated 2022-10-13 on ClinicalTrials.gov
What's tested:Total Hip Arthroplasty

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Implant Survival
Measured over 5 - 10-year follow-up

Conditions

Total Hip Replacement
Total Hip Arthroplasty

Explore related trials

Avascular NecrosisDevelopmental Dysplasia of HipInflammatory arteriopathyOsteoarthritisPsoriatic ArthritisRheumatoid ArthritisTraumatic Arthritis

Where it's being run

1 sites across 1 states
Oregon1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Implant Survival5 - 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.