Bone DiseasesNCT07379008
Safety and Efficacy of Non-Setting Paste in Bone Defect Reconstruction
A study testing Non-setting paste in people with Bone Diseases and Bone Cysts, run by Biovico Sp. z o.o. at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Diseases, Bone Cysts, Bone Neoplasm
- What is being tested?
- Non-setting paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 sitePoland
- Study dates
- 28 Feb 2023to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Use of corticosteroid-based medications
- Participation in another clinical trial
- Pregnancy or breastfeeding status
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Orthopaedics and Traumatology, Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-803
About this study
Official title: Safety and Efficacy of a Non-Setting Paste in Bone Defect Reconstruction
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.
Read the 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.
- Conditions
- Bone Diseases, Bone Cysts, Bone Neoplasm, Enchondromatosis, Bone Defects
- Being tested
- Non-setting paste
- Keywords
- Bone substitute, Bone defect reconstruction, Benign bone tumor, Bone regeneration, Osteoconductivity, Injectable bone graft, Bone remodeling
- Medical subject headings
- Bone Diseases, Bone Cysts, Bone Neoplasms, Enchondromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-setting pasteDevice
Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Device: Non-setting paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-surgery
Secondary outcomes (4)
Safety profile assessment
Comprehensive monitoring of adverse events (AEs) and serious adverse events (SAEs) using the MedDRA classification system.
Measured: 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.
Measured: 6 weeks, 6 months post-implantation
Patient Satisfaction
Evaluation of patient satisfaction with clinical trial participation and treatment outcomes using structured questionnaires.
Measured: 12 months post-surgery
Treatment discontinuation rate
Number and percentage of patients who discontinue treatment due to device-related adverse events.
Measured: Throughout 12-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start28 Feb 2023
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biovico Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379008
- Sponsor's protocol ID
- 2.0 25.01.2024
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Non-Setting Paste in Bone Defect Reconstruction
- ClinicalTrials.gov ID
- NCT07379008
- Acronym / sponsor ID
- 2.0 25.01.2024
- Conditions
- Bone Diseases, Bone Cysts, Bone Neoplasm, Enchondromatosis, Bone Defects
- Keywords
- Bone substitute, Bone defect reconstruction, Benign bone tumor, Bone regeneration, Osteoconductivity, Injectable bone graft, Bone remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Biovico Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Non-setting pasteA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-setting pasteNon-setting paste is injected into bone defects during surgical procedures for bone void reconstruction. | Device | Study group |
Primary outcome
Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months
Time frame: 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.
4 secondary outcomes
Safety profile assessment
Time frame: Throughout 12-month study period
Bone remodeling progression at 6 weeks and 6 months
Time frame: 6 weeks, 6 months post-implantation
Patient Satisfaction
Time frame: 12 months post-surgery
Treatment discontinuation rate
Time frame: Throughout 12-month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-setting paste in people with Bone Diseases and Bone Cysts, run by Biovico Sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Non-setting Paste in Bone Defect Remodeling at 12 Months (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.