Bone Cysts, Bone Defects, Bone Diseases, Bone Neoplasm, Enchondromatosis
Conditions
Keywords
Bone substitute, Bone defect reconstruction, Benign bone tumor, Bone regeneration, Osteoconductivity, Injectable bone graft, Bone remodeling
Brief summary
This study aims to evaluate the safety and efficacy of a novel bone substitute material for the treatment of bone defects in patients requiring defect filling following the excision of benign bone tumors, cysts, or similar lesions. A total of 29 patients will undergo surgical intervention during which the bone substitute paste is applied to the defect site. Patients will be followed for 12 months, with radiographic assessments to monitor bone healing. The primary objectives of the study are to assess the adequacy of bone regeneration and to evaluate the safety profile of the material.
Detailed description
This prospective, non-randomized, unblinded clinical trial evaluates a non-setting paste for bone defect reconstruction. The study is conducted at two centers in Poland (Gdańsk and Zgorzelec). The study enrolls 29 patients aged 18-75 years who require bone defect filling following curettage of benign bone tumors and tumor-like lesions (cysts, chondromas, enchondromas). Patients with inflammatory conditions, autoimmune diseases, hypersensitivity to any components, or those using medications affecting bone remodeling are excluded. Bone remodeling is assessed radiologically at 6 weeks, 6 months, and 12 months using the modified four-grade Neer classification. Success is defined as achieving Grade I (\>75% remodeling) or Grade II (51-75% remodeling) at 12 months. Secondary endpoints include safety monitoring and patient satisfaction.
Interventions
DEVICENon-setting paste
Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction.
Sponsors
Biovico Sp. z o.o.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized, unblinded, single-arm clinical trial without a control group, focusing on safety and efficacy evaluation of the bone substitute material.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Qualified for bone defect filling procedures of various origins (e.g., bone void reconstruction following curettage of benign bone tumors, cysts, chondromas) * Age 18 to 75 years * Signed informed consent form
Exclusion criteria
* Acute or chronic inflammatory conditions in the surgical area * Systemic inflammatory and autoimmune diseases * Severe degenerative diseases * Confirmed hypersensitivity to product components * Skin inflammation or dermatological disease at the surgical site * Use of medications that may affect bone remodeling (e.g., bisphosphonates) * Use of corticosteroid-based medications * Participation in another clinical trial * Pregnancy or breastfeeding status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months | 12 months post-surgery | Success is defined as achieving Grade I (\>75% bone remodeling with \>75% material resorption) or Grade II (51-75% bone remodeling with 51-75% material resorption) according to the modified four-grade Neer classification system, assessed by radiographic examination with independent expert review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile assessment | Throughout 12-month study period | Comprehensive monitoring of adverse events (AEs) and serious adverse events (SAEs) using the MedDRA classification system. |
| Bone remodeling progression at 6 weeks and 6 months | 6 weeks, 6 months post-implantation | Assessment using modified Neer classification (Grade I-IV) by radiographic examination at 6 weeks and 6 months post-surgery to evaluate the progression of bone healing over time. |
| Patient Satisfaction | 12 months post-surgery | Evaluation of patient satisfaction with clinical trial participation and treatment outcomes using structured questionnaires. |
| Treatment discontinuation rate | Throughout 12-month study period | Number and percentage of patients who discontinue treatment due to device-related adverse events. |
Countries
Poland
Outcome results
None listed