G7 Freedom Constrained Vivacit-E Liners

Официальное название

Multicenter, Prospective Post-Market Clinical Follow-Up Study of the G7® Freedom Constrained Vivacit-E® Liners

Обзор

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Подробное описание

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal of the study device and will be determined using the Kaplan-Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to the implant, instrumentation and/or procedure should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

The G7 Vivacit-E Freedom Constrained Liner is indicated for use (per IFU) as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Вмешательства

• Устройство Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
  Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners

Первичные конечные точки

• Survival of the study device [Срок оценки: 10 years]

Вторичные конечные точки (10)

• Incidence of treatment-emergent Adverse Events (safety) [Срок оценки: 10 years]
• Pain and Functional Performance - Modified Harris Hip Score [Срок оценки: 10 years]
• Pain and Functional Performance - Oxford Hip Score [Срок оценки: 10 years]
• Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L) [Срок оценки: 10 Years]
• Radiographic Performance evaluating radiolucency at 5 years follow-up [Срок оценки: 5 Years]
• Radiographic Performance evaluating osteolysis at 5 years follow-up [Срок оценки: 5 Years]
• Radiographic Performance evaluating atrophy/hypertrophy at 5 years follow-up [Срок оценки: 5 Years]
• Radiographic Performance evaluating component migration at 5 years follow-up [Срок оценки: 5 Years]
• Radiographic Performance evaluating device fracture at 5 years follow-up [Срок оценки: 5 Years]
• Radiographic Performance evaluating heterotopic ossification at 5 years follow-up [Срок оценки: 5 Years]

Критерии участия

Критерии включения

• Patient is 18 to 80 years of age, inclusive
• Patient is skeletally mature
• Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• High risk for dislocation
• Undergoing revision hip arthroplasty
• Correction of functional deformity
• In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
• Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent

Критерии исключения

• Patient is septic, has an active infection or has osteomyelitis at the affected joint
• Patient has significant osteoporosis as defined by treating surgeon
• Patient has metabolic disorder(s) which may impair bone formation
• Patient has osteomalacia
• Patient has distant foci of infections which may spread to the implant site
• Patient has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
• Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
• Patient is undergoing simultaneous bilateral THA
• Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery.
• In the opinion of the investigator, patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
• Patient is known to be pregnant
• The patient is in the vulnerable population group, such as

• a prisoner
• a known alcohol or drug abuser
• mentally incompetent or unable to understand what participation in this study entails

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 10 центров

• University of Alabama at Birmingham — Birmingham
• University of Southern California — Los Angeles
• University of Florida Board of Trustees — Gainesville
• Jersey City Medical Center, Inc — Livingston
• The Ohio State University — Columbus
• TOA Research Foundation — Knoxville
• The University of Texas Health Science Center of Houston — Houston
• Medical City Plano — Plano
• … и ещё 2 центра

Идентификаторы

NCT: NCT05587244 · CMG2021-36H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗