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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-setting paste | Device | Non-setting paste is injected into bone defects during surgical procedures for bone void reconstruction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile assessment | Comprehensive monitoring of adverse events (AEs) and serious adverse events (SAEs) using the MedDRA classification system. | Throughout 12-month study period |
| Bone remodeling progression at 6 weeks and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics and Traumatology, Medical University of Gdansk | Gdansk | Pomeranian Voivodeship | 80-803 | Poland |
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| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D001845 | Bone Cysts |
| D001859 | Bone Neoplasms |
| D004687 | Enchondromatosis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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Prospective, non-randomized, unblinded, single-arm clinical trial without a control group, focusing on safety and efficacy evaluation of the bone substitute material.
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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.
| 6 weeks, 6 months post-implantation |
| Patient Satisfaction | Evaluation of patient satisfaction with clinical trial participation and treatment outcomes using structured questionnaires. | 12 months post-surgery |
| Treatment discontinuation rate | Number and percentage of patients who discontinue treatment due to device-related adverse events. | Throughout 12-month study period |
| D010009 |
| Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |