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

Sponsor

MicroPort Orthopedics Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02309593

Collaborator

(none)

Enrollment

Location

84.7

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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) 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.

Condition or Disease	Intervention/Treatment	Phase
Joint Disease	Device: PROFEMUR® Xm Femoral Stems

Study Design

Study Type:

Observational

Actual Enrollment :

52 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Dec 21, 2021

Actual Study Completion Date :

Dec 21, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Component Survivorship [10 years post-operative]
The primary objective of this study is to estimate survivorship of all components at specified intervals out to 10 years follow-up.

Secondary Outcome Measures

Patient functional outcomes (hip specific) [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.]
To characterize total functional scores, as assessed by Oxford Hip Scores
Patient functional outcomes (quality of life) [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.]
To characterize total functional scores, as assessed by EQ-5D-3L scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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