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

Sponsor

MicroPort Orthopedics Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04147559

Collaborator

(none)

150

Enrollment

Locations

156.4

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Joint Diseases	Device: Total Hip Arthroplasty Implant

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 21, 2020

Anticipated Primary Completion Date :

May 1, 2033

Anticipated Study Completion Date :

Nov 1, 2033

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

To determine the cumulative revision rate at specified intervals out to 10 years follow-up [10 years post-operative]
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.
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS. [10 years post-operative]
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.
Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L [10 years post-operative]
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.
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS). [10 years post-operative]
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.
To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey. [10 years post-operative]
The Satisfaction Survey consists of questions asked about how satisfied the patient is with the new implant.
To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem [10 years post-operative]
Radiolucencies are described around 7 zones and will be reporting the number of hips with radiolucencies present at a given zone.
To characterize adverse events and adverse device effects [10 years post-operative]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.
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:

Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
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 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
Unwilling or unable to sign the Informed Consent document
Has documented substance abuse issue
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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute	Scottsdale	Arizona	United States	85258
2	HCA Research Institute, OrthoONE at Swedish Medical Center	Englewood	Colorado	United States	80113