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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Joint Diseases
• Intervention / Treatment: Device: Total Hip Arthroplasty Implant

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Research Institute
  • Colorado
    • Englewood, Colorado, United States, 80113
      • HCA Research Institute, OrthoONE at Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects either newly or previously implanted with the PROFEMUR® Preserve Classic Stem combined with other Wright MEdical Technology (WMT) or MPO THA components.

Description

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 -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Component Survivorship	The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the cumulative revision rate at specified intervals out to 10 years follow-up	Percentage of hips that were revised or replaced at each of the intervals for Year 1, Year 3, Year 5, Year 7 and Year 10 evaluation.	10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.	The study will be reporting the final Hip Disability and Osteoarthritis Outcome Score (HOOS) which ranges from 0 to 100 with a score of 0 indicating worst hip symptoms and 100 indicating no hip symptoms.	10 years post-operative
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L	EQ-5D-5L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 5 levels: no problems, slight problem, moderate problem, severe problem, inability to perform the activity. With no problems being the best outcome and inability to perform the activity being worst outcome.	10 years post-operative
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS).	The study will be reporting forgotten joint score measures for the assessment of joint-specific patient reported outcomes. The questions focus on the patients' awareness of the implanted joint in everyday life or any unintended perception of a joint.	10 years post-operative
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.	The Satisfaction Survey consists of questions asked about how satisfied the patient is with the new implant.	10 years post-operative
To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem	Radiolucencies are described around 7 zones and will be reporting the number of hips with radiolucencies present at a given zone.	10 years post-operative
To characterize adverse events and adverse device effects	Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effects (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will also be provided.	10 years post-operative

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Joseph Assini, MD, OrthoOne at Swedish Medical Center; Principal Investigator: Judd Cummings, MD, HonorHealth Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): November 1, 2033

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; avascular necrosis; ankylosis; protrusio acetabuli; painful hip dysplasia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 19H001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes