Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems

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) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.

Study Overview

• Status: Terminated
• Conditions: Joint Disease
• Intervention / Treatment: Device: PROFEMUR® Xm Femoral Stems

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Germany
  • Mülheim/Ruhr, Germany, 45468
    • St. Marien-Hospital Mülheim, Klinik für Orthopädie, Unfall & Wiederherstellungschirurgie

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells.

Description

Inclusion Criteria:

• Subject previously underwent / is a candidate for primary THA for any of the following:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia
• Inflammatory degenerative joint disease such as rheumatoid arthritis; or
• Correction of functional deformity
• Subject has been previously implanted / is a candidate to be implanted with the specified combination of components
• Subject is willing and able to complete required study visits or assessments
• Not previously implanted subject is able to undergo primary THA procedure

Previously implanted bilateral subjects can have both THAs enrolled in the study provided:

• the specified combination of components were implanted in both
• all other aspects of the Inclusion/Exclusion Criteria are satisfied
• enrollment does not exceed the subject count specified in the Clinical Trial Agreement
• the subject agrees to a second Informed Consent document specific to the second THA

Prospective enrollment of a previously unimplanted contralateral hip is permitted in this study provided:

• it occurs not more than two years after the index THA
• the specified combination of components is used
• all other aspects of the Inclusion/Exclusion Criteria are satisfied
• enrollment does not exceed the subject count specified in the Clinical Trial Agreement
• the subject agrees to a second Informed Consent document specific to the second THA

Exclusion Criteria:

• Subject is skeletally immature (less than 21 years of age) at time of primary THA surgery
• Subject is currently enrolled in another clinical study which could affect the endpoints of this protocol
• Subject is unwilling to sign the Informed Consent document
• Subject has substance abuse issues
• Subject is incarcerated or has pending incarceration
• Subject is anticipated to require a contralateral THA less than 1 year after the index THA on the enrolled hip

In addition, not previously implanted subjects will be excluded if they meet any of the following criteria:

• Subject has any of the following contraindications at the time of implantation
• Overt infection
• Distant foci of infections (which may cause hematogenous spread to the implant site)
• Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram
• 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
• Neuropathic joints
• Hepatitis or HIV infection
• Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PROFEMUR® Xm Femoral Stems; Single study group either previously implanted or will be implanted with the following combination of components: PROFEMUR® Xm Femoral Stems, with any type of Acetabular Shells.	Device: PROFEMUR® Xm Femoral Stems; THA using PROFEMUR® Xm Femoral Stems; Other Names: Primary hip replacement device

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 survivorship of all components at specified intervals out to 10 years follow-up.	10 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient functional outcomes (hip specific)	To characterize total functional scores, as assessed by Oxford Hip Scores	Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.
Patient functional outcomes (quality of life)	To characterize total functional scores, as assessed by EQ-5D-3L scores	Previously implanted subjects: 6 months, 1, 3, 5, 7, and 10 years postoperatively beginning with first available visit; not previously implanted subjects: Pre-operative, 6 months, 1, 3, 5, 7, and 10 years postoperatively.

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Investigators: Principal Investigator: Marcus Jäger, MD, St. Marien-Hospital Mülheim

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; correction of functional deformity; ankylosis; protrusio acetabuli; painful hip dysplasia; revision procedures
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002A

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