Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems
- Conditions
- M24M25Other specific joint derangementsOther joint disorders, not elsewhere classified
- Registration Number
- DRKS00007617
- Lead Sponsor
- MicroPort Scientific Cooperatief U.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 64
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:
-Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
-Subjects currently enrolled in another clinical study
-Subjects unwilling to sign the Informed Consent document
-Subjects with 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 & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to estimate survivorship using Kaplan Meier analysis of all components at specified intervals out to 10 years follow-up. This is done by capturing whether a revision is done yes/no, when the patient comes in for a routine follow-up visit (6 months, 1, 3, 5, 6, and 10 years post-operatively).
- Secondary Outcome Measures
Name Time Method The secondary objective is to characterize total functional scores for subjects, as assessed by Oxford Hip Scores and EQ-5D-3L Scores. These questionnaires are filled out by the patient pre-operatively and 6 months, 1, 3, 5, 7, and 10 years post-operatively.