Bone Deformity Clinical Trial
Official title:
Prospective Multicenter Observational Study on the Use of NEOCEMENT® for the Treatment of Bone Defects
Verified date | January 2023 |
Source | Bioceramed |
Contact | Ana Manjua, PhD |
Phone | +351917931592 |
amanjua[@]bioceramed.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Neocement is a CE marked device, registered in INFARMED (Portuguese National Competent Authority) and Department of Planning and Organisation of the National Health Service - General board of Medical Devices, pharmaceutical services, and safety in healthcare (Italy). This protocol does not include any new intended uses, new populations, new materials or design changes.
Status | Not yet recruiting |
Enrollment | 165 |
Est. completion date | June 5, 2026 |
Est. primary completion date | December 5, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with bone defect treatment who meet predefined criteria in Instructions For Use (IFU) of Neocement® / Neocement® Inject P. - Age = 18 years of both genders (male and female) - Patient signed informed consent form (for data collection) - Bone defects surgically created or osseous defects created from traumatic injury to the bone - Bone skeletal defects that are not intrinsic to the stability of bone structure OR site which can be stabilized Exclusion Criteria: - Acute or chronic infection at the surgical site; - Metabolic bone diseases; - Severe degenerative disease conditions in which general bone grafting is not advisable; - Active malignancy. - Inability to understand consent and objectives of the study; - Pregnant women or breastfeeding women; - Unable to undergo medical monitoring for geographical, social or psychological reasons. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bioceramed | European Clinical Research Infrastructure Network, Horizon 2020 - European Commission |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Assess patients' health during recovery | 24 months | |
Other | Quality of life measured through the SF-36 Questionnaire | Collect usability feedback on the device | 24 months | |
Other | Technical success rate | Successful delivery of the bone substitute in the bone defect | 24 months | |
Primary | Bone consolidation (Neer/ RUST classification) | Neer classification is used for trabecular bone:
Healed: Cyst filled by new bone, with or without small radiolucent area(s) < 1 cm in size Healing with defects: Radiolucent area(s) < 50% of the diameter of bone, with enough cortical thickness to prevent fracture Persistent cyst: Radiolucent area > 50% of diameter of the bone and with a thin cortical rim. No increase in the size of the cyst. Recurrent cyst: Cyst reappeared in a previously obliterated area, or a residual radiolucent area has increased in size) RUST is classified according to the scores: Score 1: Fracture Line, No Callus Score 2: Fracture Line, Visible Callus Score 3: Fracture Line, Bridging Callus Score 4: No fracture line, remodelled |
24 months | |
Secondary | Functional scores | Functional scores are classified as Hip disability and Osteoarthritis Outcome Score, Knee disability and Osteoarthritis Outcome Score, Foot and Ankle Ability Measure, where 0 points is the worst possible score and 100 points is the best possible score. | 24 months |
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