Status:
TERMINATED
Post Market Clinical Follow-up Study Protocol for PROFEMUR® Xm Femoral Stems
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Joint Disease
Eligibility:
All Genders
21+ years
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02309593
Start Date
December 1 2014
End Date
December 21 2021
Last Update
April 28 2022
Active Locations (1)
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1
St. Marien-Hospital Mülheim, Klinik für Orthopädie, Unfall & Wiederherstellungschirurgie
Mülheim, Germany, 45468