Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Component Survivorship [Срок оценки: 10 years post-operative]

Вторичные конечные точки (7)

• To determine the cumulative revision rate at specified intervals out to 10 years follow-up [Срок оценки: 10 years post-operative]
• Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS. [Срок оценки: 10 years post-operative]
• Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L [Срок оценки: 10 years post-operative]
• To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS). [Срок оценки: 10 years post-operative]
• To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey. [Срок оценки: 10 years post-operative]
• To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem [Срок оценки: 10 years post-operative]
• To characterize adverse events and adverse device effects [Срок оценки: 10 years post-operative]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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 -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• HonorHealth Research Institute — Scottsdale
• HCA Research Institute, OrthoONE at Swedish Medical Center — Englewood

Идентификаторы

NCT: NCT04147559 · 19H001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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