Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Hip Arthroplasty Implant.
- Who it may be relevant to
- Registry conditions: Joint Diseases. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Total Hip Arthroplasty Implant
Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.
Primary outcome measures
- Component Survivorship [Time frame: 10 years post-operative]
Secondary outcome measures (7)
- To determine the cumulative revision rate at specified intervals out to 10 years follow-up [Time frame: 10 years post-operative]
- Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS. [Time frame: 10 years post-operative]
- Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L [Time frame: 10 years post-operative]
- To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS). [Time frame: 10 years post-operative]
- To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey. [Time frame: 10 years post-operative]
- To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem [Time frame: 10 years post-operative]
- To characterize adverse events and adverse device effects [Time frame: 10 years post-operative]
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
- 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
- Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Unwilling or unable to sign the Informed Consent document
- Has documented substance abuse issue
- Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
- Currently incarcerated or has impending incarceration
- 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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- HonorHealth Research Institute — Scottsdale
- HCA Research Institute, OrthoONE at Swedish Medical Center — Englewood
Identifiers
NCT: NCT04147559 · 19H001