Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

NCT ID: NCT04147559

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2033-11-01

Brief Summary

Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.

Conditions

Joint Diseases

Study Design

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

Interventions

Total Hip Arthroplasty Implant

Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.

Intervention Type: DEVICE

Other Intervention Names

PROFEMUR® Preserve Classic Femoral Stem

Eligibility Criteria

Inclusion Criteria

1. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.

2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity 3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit 4. Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.

Exclusion Criteria

1. Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)

2. Skeletally immature (less than 21 years of age) at time of implantation

3. Has or had an overt infection at the time of implantation

4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation

5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation

6. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable

7. Has or had neuropathic joints

8. Has or had hepatitis or HIV infection

9. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing

10. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques

11. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol

12. Unwilling or unable to sign the Informed Consent document

13. Has documented substance abuse issue

14. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

15. Currently incarcerated or has impending incarceration

16. Has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol -

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Assini, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoOne at Swedish Medical Center

Judd Cummings, MD

Role: PRINCIPAL_INVESTIGATOR

HonorHealth Research Institute

Locations

HonorHealth Research Institute

Scottsdale, Arizona, United States

HCA Research Institute, OrthoONE at Swedish Medical Center

Englewood, Colorado, United States

Countries

United States

Other Identifiers

19H001

Identifier Type: -

Identifier Source: org_study_id