An interventional study of Non-setting paste in Bone Diseases, Bone Cysts and Bone Neoplasm, sponsored by Biovico Sp. z o.o.. Completed at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Biovico Sp. z o.o. · Not applicable, Interventional, and Treatment
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.
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.
177 studies on the registry are indexed under Bone Diseases; 38 are open to participants now.
This study's enrollment of 29 is below the median of 53 across 113 interventional studies indexed under Bone Diseases.
Browse Bone Diseases studies →Biovico Sp. z o.o. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Non-setting paste
Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction.
Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months
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.
Time frame: 12 months post-surgery
Safety profile assessment
Comprehensive monitoring of adverse events (AEs) and serious adverse events (SAEs) using the MedDRA classification system.
Time frame: Throughout 12-month study period
Bone remodeling progression at 6 weeks and 6 months
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.
Time frame: 6 weeks, 6 months post-implantation
Patient Satisfaction
Evaluation of patient satisfaction with clinical trial participation and treatment outcomes using structured questionnaires.
Time frame: 12 months post-surgery
Treatment discontinuation rate
Number and percentage of patients who discontinue treatment due to device-related adverse events.
Time frame: Throughout 12-month study period
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Nov 2025, 32 months.
Of 25 interventional studies with no phase under Bone Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 54. This study's 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Biovico Sp. z o.o.