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

NCT04615039 | Withdrawn FDA Device

• 1 other identifier: 19H001C
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Component Survivorship

  To estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem at 1, 3, 5, 7, 10 years.

  10 years post-operative

Secondary Outcomes (7)

• HOOS Functional Scores

  10 years post-operative

• EQ-5D-5L Functional Scores

  10 years post-operative

• Subject Satisfaction as assessed by Forgotten Joint Score

  10 years post-operative

• Subject Satisfaction as assessed by Satisfaction Survey

  10 years post-operative

• Radiolucencies

  10 years post-operative

Interventions

PROFEMUR® Preserve Classic Femoral Stem DEVICE

Single study group of subjects, either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with any type of polyethylene and ceramic acetabular shells, acetabular liners and femoral heads.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with any type of polyethylene and ceramic acetabular shells, acetabular liners and femoral heads.

You may qualify if:

• Has previously undergone or currently has been determined to undergo a primary THA with the study component MPO PROFEMUR® Preserve Classic Stem combined with any type of polyethylene or ceramic acetabular shells, acetabular liners and femoral heads.
• 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
• Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
• Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary THA implantation.

You may not qualify if:

• Skeletally immature (less than 21 years of age) at time of implantation
• Has or had an overt infection at the time of implantation
• Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
• Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
• 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
• Has or had neuropathic joints
• Has or had hepatitis or HIV infection
• Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
• Has or had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
• Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
• Has or had documented substance abuse issues
• Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
• Currently incarcerated or has impending incarceration
• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Design

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

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share