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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Implant Survival — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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