FlexiOss® - Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration.

Official title

A Prospective, Randomized, Double-blinded, Multi-center, Non-inferiority Study Evaluating the Efficacy, Safety and Long-term (Radiological and Clinical) Outcomes During Comprehensive Care Continuum of Implanted Biocomposite for Bone Regeneration FlexiOss® Compared to the Current Standard of Care in Patients With Primary Acute Trauma Bone Defects.

Overview

The aim of this clinical study is to evaluate the efficacy, safety and long-term (radiological and clinical) outcomes during comprehensive care continuum of implanted biocomposite for bone regeneration FlexiOss® compared to the current standard of care in patients with primary acute trauma bone defects. The efficacy, safety and long-term (radiological and clinical) evaluation will be assessed during follow up visits at 2, 6 weeks, 3, 6, 12 and 24 months.

Interventions

• Device FlexiOss®
  Bone reconstruction with FlexiOss® biocomposite.
• Procedure Allogenic human bone grafting
  Implantation of allogenic human bone graft.

Primary outcome measures

• Efficacy endpoint [Time frame: At 24-month follow-up]
• Number and Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 24 months]
• Improvement of load-bearing capacity with simultaneously reduction of lower extremity dysfunction in the period before and after rehabilitation based on a PROMs (LEFS scale) over 24 months [Time frame: At 2-week, 6-week, 3-month, 6-month, 12-month & 24-month follow-up]
• Non-deterioration in Quality of Life (QoL) after completing rehabilitation based on SF-36 questionnaire score. [Time frame: Up to 24 months]

Secondary outcome measures (9)

• Lack of reinterventions in the treated area within 24 months. [Time frame: Up to 24 months]
• Full load on the treated limb during physical examination (lower limb bones) at 2 and 6 weeks; 3, 6, 12 and 24 months. [Time frame: At 2 and 6 weeks; 3, 6, 12 and 24 months]
• Full mobility of the treated limb during physical examination expressed as active or passive range of motions specific to the studied region at 2 and 6 weeks; 3, 6, 12 and 24 months. [Time frame: At 2 and 6 weeks; 3, 6, 12 and 24 months]
• Lack of bone lysis in X-ray after 12 and 24 months (preserving joint surface alignment). [Time frame: After 12 and 24 months]
• Assessment of changes in levels of calcium in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months. [Time frame: At screening, 6 weeks, 6, 12, 24 months]
• Assessment of changes in levels of phosphates in blood after biocomposite implantation during follow-up at screening, 6 weeks, 6, 12, 24 months. [Time frame: At screening, 6 weeks, 6, 12, 24 months]
• Proper bone union observed in imaging examination (X-ray) after 6 and 12 months. [Time frame: After 6 and 12 months]
• Assessment of PROM - LEFS obtained individual results at discharge; 2 and 6 weeks; 3, 6, 12 and 24 months. [Time frame: At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months]
• Assessment of PROM - SF-36 obtained individual results at discharge; 2 and 6 weeks; 3, 6, 12 and 24 months. [Time frame: At baseline; 2 and 6 weeks; 3, 6, 12 and 24 months]

Eligibility criteria

Inclusion criteria

• Age between 18 and 75 years.
• Subject signed informed consent form and is willing to participate in the follow-up visits.
• Subject with an existing acute primary bone defect in one of the following groups:

• Long bones of the lower extremity (including articular tibia plateau acute fracture).
• Bones of the foot (including articular calcaneus acute fracture).
• Subject scheduled for orthopedic procedure with bone substitute material.

Exclusion criteria

• Subject with alcohol dependence syndrome or any history of substance abuse within the past year.
• Pregnancy or breastfeeding.
• Subject participates in another clinical trial.
• Unstable mental condition or psychiatric concomitant disease.
• Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration.
• Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material
• Subject with active cancer disease and/or during related oncological treatment.
• Contraindications for computed tomography angiography according to the site Standard of Care include, but are not limited to, allergic reactions to contrast agents and impaired renal function.
• Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation.
• Any other condition precluding implantation of FlexiOss®.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Poland · 2 centers

• Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ — Krakow
• Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kl — Otwock

Identifiers

NCT: NCT07209033 · 24-MED-0003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗