MFinity BE Pre-market Trial

Официальное название

Prospective Single-arm Clinical Study Assessing the Safety and Effectiveness of a Novel Femoral Stem for Total Hip Arthroplasty.

Обзор

The primary objective of this trial is to determine the implant survival at 1 year of follow up in a population of patients undergoing primary Total Hip Replacement with MFinity Collared Femoral stem and to test its non-inferiority compared to other cementless implant (as reported by the EPRD registry).

Подробное описание

This prospective study aims to assess the clinical and radiographic outcomes of patients undergoing THA with implantation of MFinity femoral stems to determine the safety and performance of the implant in comparison with registry data for uncemented THA.

Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.

The study is conducted according to the following schedule:

* V1 : Inclusion during a preoperative visit * V2: Surgery * V3: Follow-up visit at 6 week post-surgery * V4: Follow-up visit at 3 months post-surgery * V5: Follow-up visit at 12 months post-surgery * V6: Follow-up visit at 24 months post-surgery

The following data will be collected:

* Rate of complications, Device Deficiencies and Adverse Events * HHS and FJS at 6 weeks, 3 months, 1 and 2 years postoperatively * Radiologic evaluations at immediate postoperative assessment, 3 months, 1 and 2 years postoperatively

A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).

The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.

Вмешательства

• Устройство Mfinity collared stem
  The MFinity Femoral Stem is intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The devices are made of Ti6Al7Nb and coated in the proximal end of the shaft with TiGrowth-C titanium. The thickness of the Ti coating is 700μm while the thickness of the HA coating is 80μm.

Первичные конечные точки

• Implant survival rate (%) assessed by Kaplan-Meier analysis at 1 year [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Implant survival rate (%) assessed by Kaplan-Meier analysis at 2 years [Срок оценки: 2 years]
• Harris Hip Score [Срок оценки: Pre-op, 6 weeks, 3 months, 1 and 2 years]
• Forgotten Joint Score-12 (FJS-12) [Срок оценки: Pre-op, 6 weeks, 3 months, 1 and 2 years]
• Incidence of device deficiencies [Срок оценки: From surgery to 2 years post-operatively]
• Incidence of adverse events and serious adverse events [Срок оценки: From surgery to 2 years post-operatively]
• Radiological analysis [Срок оценки: 3 months, 1 and 2 years postoperatively]

Критерии участия

Критерии включения

• Patients undergoing elective primary total hip arthroplasty for primary osteoarthritis, who are suitable for implantation of a cementless femoral stem according to the MFinity femoral stem Instructions for Use
• Skeletally mature adult aged 18 years and older at the time of enrollment.
• Ability to give informed consent.
• Patient is informed of the conditions of the study and is willing to participate for the length of the prescribed follow-up period.

Критерии исключения

• Not meeting the inclusion criteria.
• Active infection within the affected hip joint.
• Previous total hip replacement or hip fusion of the affected hip joint.
• Neuromuscular or neurosensory deficiency limiting the ability to evaluate the safety and effectiveness of the device.
• Bone condition that may compromise the stability of the implant
• Known allergy or hypersensitivity to the implant material
• Immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
• For women of childbearing potential\*: a positive pregnancy test
• Patients with severe osteoarthritis in the contralateral hip or other joints that may interfere with the assessment of study outcomes.
• Patients who have previously participated in this clinical trial.

• a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women using one of the following birth control methods are not considered of childbearing potential: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable),intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, and sexual abstinence.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07616895 · P01.035.03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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