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

Active, not recruiting

• Conditions: Joint Disease
• Interventions: Device: PROFEMUR® Preserve Femoral Stem

• Registration Number: NCT03865667
• Lead Sponsor: MicroPort Orthopedics Inc.

Brief Summary

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Primary Completion: 2032-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects will be excluded if they meet any of the following criteria:

• Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners);
• Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck;
• Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery;
• Subjects have or had an overt infection at the time of implantation;
• Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation;
• Subjects have or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at time of implantation;
• Subjects have 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;
• Subject has neuropathic joints;
• Subject has hepatitis or HIV infection;
• Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing;
• Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol;
• Subjects unwilling or unable to sign the Informed Consent document;
• Subjects with documented substance abuse issues;
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study;
• Subjects who are incarcerated or have pending incarceration.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Total Hip Arthroplasty	PROFEMUR® Preserve Femoral Stem	Single-arm, single-center, prospective follow-up study with consecutively enrolled newly or previously implanted subjects with the PROFEMUR® Preserve Femoral Stem(s) and CoCr (cobalt-chromium) Modular Neck combined with other Wright Medical Technologies (WMT) or MPO (MicroPort) THA (Total Hip Arthroplasty) components including acetabular shells, acetabular liners and femoral heads.

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to evaluate component survivorship of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck out to 10 years follow-up.	10 years	Percentage of hips survived with no revision or replacement at 10-year.

Secondary Outcome Measures

Name	Time	Method
To determine the cumulative incidence of component revision of the PROFEMUR® Preserve Femoral Stem and CoCr Modular Neck at specified intervals out to 10 years follow-up.	Time Frame: 2-5 years, 5-7 years, and 10 years	Percentage of hips that were revised or replaced at each of the intervals namely for Early (2-5 years), midterm (5-7 Year), and long-term (10-year) evaluation.
To characterize functional scores, as assessed by Oxford Hip and EQ-5D-3L scores.	Time Frame: 2-5 years, 5-7 years, and 10 years	The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'. EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems.
To evaluate the presence and the zones of radiolucencies surrounding the implanted femoral components.	2-5 years, 5-7 years, and 10 years	Radiolucencies are described around 7 zones and we will be reporting the number of hips with radiolucencies present at a given zone.
To characterize of adverse events and adverse device effects.	2-5 years, 5-7 years, and 10 years	Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effect (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will be also provided.

Trial Locations

Locations (1)

Dr. Manel Ribas; 🇪🇸 Barcelona, Spain