BONE SUBSTITUTES OUTCOMES

Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374342
• Other study ID #: SO01-TK-SUBSTITUTES
• Status: Recruiting
• Start date: September 16, 2021
• Est. completion date: September 30, 2032

Study information

• Verified date: April 2024
• Source: Teknimed
• Contact: Solange VAN DE MOORTELE, PhD
• Phone: +33534252679
• Email: s.vandemoortele[@]teknimed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 425
• Est. completion date: September 30, 2032
• Est. primary completion date: September 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Device:
• 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.
• Spine fusion
Spinal fusion is a surgery procedure that reinforces your back structure and stability by linking two vertebrae together
• 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.

Locations

Country	Name	City	State
France	Clinique du Pré	Le Mans	Sarthe
France	Pôle Rachis Hôpital Privé d'Eure et Loir	Mainvilliers	Eure Et Loir
France	CHRU Brabois	Nancy	Meurthe Et Moselle
France	Clinique Médipole Garonne	Toulouse	Haute Garonne
France	Hôpital Joseph Ducuing	Toulouse	Haute Garonne
Germany	OCM Klinik GmbH	München	Bavière

Sponsors (1)

Lead Sponsor	Collaborator
Teknimed

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful bone repair	Evaluated through the rate of revision surgery due to a failure of the substitute.	24 months
Secondary	Alleviation of Pain	Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits	24 months
Secondary	Bone reconstruction	Evaluated on X-Rays by the Lane and Shadu score and the healing stage	24 months
Secondary	Well-being	Evaluated through a series of short questions : On a scale from 0 (Not at all) to 10 (Perfectly well); Are you satisfied with your global health status? _____ / 10; Do you manage to carry out your day-to-day activities? _____ / 10; Do you manage to achieve what you would like? _____ / 10; Do you feel relaxed _____ / 10; Do you feel fit / with energy? _____ / 10; Do your physical, psychic and emotional conditions allow you to enjoy your relationships with others? _____ / 10	24 months
Secondary	Patient satisfaction	Evaluated through a series of short questions A. Are you satisfied with your surgery? YES/NO/Without opinion B. Has your health improved? YES/STABLE/NO C. Given the results, would you do this intervention again? YES/NO/Without opinion	24 months