NCT04147559
Enrolling By Invitation
Not Applicable
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
MicroPort Orthopedics Inc.2 sites in 1 country150 target enrollmentStarted: October 21, 2020Last updated:
ConditionsJoint Diseases
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- MicroPort Orthopedics Inc.
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Component Survivorship
Overview
Brief Summary
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.
- •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
- •Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit
- •Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.
Exclusion Criteria
- •Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
- •Skeletally immature (less than 21 years of age) at time of implantation
- •Has or had an overt infection at the time of implantation
- •Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
- •Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
- •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
- •Has or had neuropathic joints
- •Has or had hepatitis or HIV infection
- •Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
- •Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
Outcomes
Primary Outcomes
Component Survivorship
Time Frame: 10 years post-operative
The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.
Secondary Outcomes
- To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem(10 years post-operative)
- Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.(10 years post-operative)
- To characterize adverse events and adverse device effects(10 years post-operative)
- To determine the cumulative revision rate at specified intervals out to 10 years follow-up(10 years post-operative)
- To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS).(10 years post-operative)
- To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.(10 years post-operative)
- Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L(10 years post-operative)
Investigators
Study Sites (2)
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