Bone Substitutes Outcomes - Post Market Follow-up

Официальное название

Safety and Clinical Performance Assessment of Bone Substitutes Used for Bone Voids Filling - A Post-Market Clinical Follow-Up

Обзор

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels. TEKNIMED bone substitutes are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.

Подробное описание

It is admitted that:

* Surgeons are often concerned by bone void filling and they can choose between synthetic bone substitutes or bone grafts of animal or human origin. * Due to their chemical composition similar to bone tissue, synthetic bone substitutes are an interesting alternative to autografts and allografts which present some inconvenient (quantity to sample, infection of sampling site…). * Bone substitutes are bioresorbable and replaced by bone during the healing process (bone remodelling). * Nowadays, bone substitutes represent a common and efficient procedure to treat surgical or traumatic osseous defects. They are indicated and used in various pathologies and types of surgery, but they always have the same intended use: to fill a bone void. * Bone substitutes are also used in spine surgeries for cage filling and/or posterolateral fusion.

TEKNIMED has developed several bone substitutes currently used in various types of surgery. Due to their increasing use, there is a need of real-life safety and efficacy data on these products.

This retro-prospective study is performed to assess the safety and performance of TEKNIMED bone substitutes in their current clinical use.

Вмешательства

• Устройство Bone defect
  Bone grafting is a procedure where damaged bones can be repaired or rebuilt using transplanted bone from another source. Sources for transplant bone include the patient (autograft), a cadaver (allograft) or synthetic bone.
• Устройство Spine fusion
  Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
• Устройство Cage filling
  Intervertebral fusion with cages is a surgical procedure used to stabilize the spine by fusing adjacent vertebrae. The cages, typically made of materials like titanium or plastic, and pre-filled with bone graft substitutes are placed between the vertebrae to maintain the proper spacing and alignment.

Первичные конечные точки

• Successful bone repair [Срок оценки: 24 months]

Вторичные конечные точки (4)

• Alleviation of Pain [Срок оценки: 24 months]
• Bone reconstruction [Срок оценки: 24 months]
• Well-being [Срок оценки: 24 months]
• Patient satisfaction [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Be 18 years or older.
• Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France) and

o For prospective inclusion:

• Be considered for a surgery where bone filling with one of the TEKNIMED bone substitutes comprised in this study is needed and intended to be used according to the IFU.

o For retrospective inclusion:

• Have undergone a surgery with a TEKNIMED bone substitute used according to the IFU, between the 1st January 2015 and the date of the site initiation visit
• Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent (where applicable) during the first follow-up visit following the site initiation.

Критерии исключения

Patients presenting one of the following conditions will not be included:

• Under trusteeship or guardianship
• Pregnancy or breast-feeding women

According to contraindications per IFU:

• Procedures other than those stated in the INDICATIONS section
• Patients susceptible to allergic reactions to the product components.

CERAFORM®, TRIHA+®:

\- Treatment of large bone defects which could impact the stability of bone structure without implementing a mechanical stabilisation system (such as plate(s), screw(s), nail(s), cage(s))

NANOGEL®:

• Use in vertebroplasty procedures
• Subcutaneous use

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 5 центров

• Pôle Rachis Hôpital Privé d'Eure et Loir — Mainvilliers
• Hôpital Joseph Ducuing — Toulouse
• Clinique Médipole Garonne — Toulouse
• CHRU Brabois — Nancy
• Clinique du Pré — Le Mans

Германия · 1 центр

• OCM Klinik GmbH — München

Идентификаторы

NCT: NCT06374342 · SO01-TK-SUBSTITUTES

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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