Clinical trial · Interventional
Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction
Safety and Efficacy of a Non-Setting Paste in Bone Defect Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Cysts | — | UNRESOLVED | — |
| Bone Defects | — | UNRESOLVED | — |
| Bone Diseases | — | UNRESOLVED | — |
| Bone Neoplasm | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Enchondromatosis | Enchondromatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-setting paste | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study group
- description
- A total of 29 patients, aged 18 to 75, who required bone defect filling following curettage of benign bone tumors or tumor-like lesions, underwent surgical implantation of a non-setting bone substitute paste to fill the resulting defects.
- interventionNames
- Device: Non-setting paste
Primary outcomes (1)
- measure
- Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months
- timeFrame
- 12 months post-surgery
- description
- 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 outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available