CompletedNot Applicable

Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction

Poland29 participantsStarted 2023-02-28

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months

Timeframe: 12 months post-surgery

Trial details

NCT IDNCT07379008

SponsorBiovico Sp. z o.o.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-12

View on ClinicalTrials.gov More Bone Diseases trials