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

NCT ID: NCT04277416

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2032-12-31

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.

Detailed 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.

Conditions

Total Hip Replacement; Total Hip Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Total Hip Arthroplasty

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Ortho Development Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oregon Health Sciences University

Portland, Oregon, United States

Countries

United States

Other Identifiers

P-19-0055

Identifier Type: -

Identifier Source: org_study_id