Clinical trial NCT04615039: Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem
Official title: Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Joint Diseases
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Has previously undergone or currently has been determined to undergo a primary THA with the study component MPO PROFEMUR® Preserve Classic Stem combined with any type of polyethylene or ceramic acetabular shells, acetabular liners and femoral heads.
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:

1. Skeletally immature (less than 21 years of age) at time of implantation
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

Primary outcomes:
measure: Component Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: HOOS Functional Scores
timeFrame: 10 years post-operative
measure: EQ-5D-5L Functional Scores
timeFrame: 10 years post-operative
measure: Subject Satisfaction as assessed by Forgotten Joint Score
timeFrame: 10 years post-operative
measure: Subject Satisfaction as assessed by Satisfaction Survey
timeFrame: 10 years post-operative
measure: Radiolucencies
timeFrame: 10 years post-operative
measure: To assess subject safety
timeFrame: 10 years post-operative
measure: To assess device tolerability within subject
timeFrame: 10 years post-operative
Other outcomes:
Locations:
Study officials:
References: