Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem
NCT ID: NCT04615039
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-12-31
2033-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Interventions
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PROFEMUR® Preserve Classic Femoral Stem
Single study group of subjects, either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with any type of polyethylene and ceramic acetabular shells, acetabular liners and femoral heads.
Eligibility Criteria
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Inclusion Criteria
2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:
* non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
* inflammatory degenerative joint disease such as rheumatoid arthritis;
* correction of functional deformity
3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
4. Previously implanted subjects must be enrolled within 3 years (+ 6 months) of their primary THA implantation.
Exclusion Criteria
2. Has or had an overt infection at the time of implantation
3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
5. Has 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
6. Has or had neuropathic joints
7. Has or had hepatitis or HIV infection
8. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
9. Has or had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
10. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
11. Has or had documented substance abuse issues
12. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
13. Currently incarcerated or has impending incarceration
14. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
21 Years
ALL
No
Sponsors
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MicroPort Orthopedics Inc.
INDUSTRY
Responsible Party
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Other Identifiers
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19H001C
Identifier Type: -
Identifier Source: org_study_id