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

NCT04277416 | Enrolling By Invitation FDA Device

• 1 other identifier: P-19-0055
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Hip Replacement; Total Hip Arthroplasty

Keywords

Ortho Development; Entrada Hip System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Implant Survival

  2 - 10 year follow-up

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

  2 - 10-year follow-up

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

  2 - 10-year follow-up

• UCLA Activity Rating Scale

  2 - 10-year follow-up

• Patient Satisfaction

  2 - 10-year follow-up

Study Arms (1)

Entrada Hip System

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

Interventions

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.

Entrada Hip System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \. 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

You may not qualify if:

• 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.
• Any other contraindication to THA listed in the Entrada™ Hip Stem Labelling or Instructions for Use.

Sponsors & Collaborators

• Ortho Development Corporation: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: February 20, 2020
• Study Start: February 28, 2020
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)