Clinical trial NCT04147559: Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Official title: Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Joint Diseases
Keywords: Osteoarthritis
avascular necrosis
ankylosis
protrusio acetabuli
painful hip dysplasia
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects either newly or previously implanted with the PROFEMUR® Preserve Classic Stem combined with other Wright MEdical Technology (WMT) or MPO THA components.

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 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.

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 of their primary THA implantation.

Exclusion Criteria:

1. Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
2. Skeletally immature (less than 21 years of age) at time of implantation
3. Has or had an overt infection at the time of implantation
4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
6. 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
7. Has or had neuropathic joints
8. Has or had hepatitis or HIV infection
9. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
10. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
11. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
12. Unwilling or unable to sign the Informed Consent document
13. Has documented substance abuse issue
14. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
15. Currently incarcerated or has impending incarceration
16. 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: To determine the cumulative revision rate at specified intervals out to 10 years follow-up
timeFrame: 10 years post-operative
measure: Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS.
timeFrame: 10 years post-operative
measure: Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L
timeFrame: 10 years post-operative
measure: To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS).
timeFrame: 10 years post-operative
measure: To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey.
timeFrame: 10 years post-operative
measure: To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem
timeFrame: 10 years post-operative
measure: To characterize adverse events and adverse device effects
timeFrame: 10 years post-operative
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Research Institute
state: Arizona
city: Englewood
country: United States
facility: HCA Research Institute, OrthoONE at Swedish Medical Center
state: Colorado
Study officials:
affiliation: OrthoOne at Swedish Medical Center
name: Joseph Assini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HonorHealth Research Institute
name: Judd Cummings, MD
role: PRINCIPAL_INVESTIGATOR
References: