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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04645186
Other study ID # 2019.04
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 5, 2020
Est. completion date June 1, 2023

Study information

Verified date January 2022
Source Bioceramed
Contact A.C. Manjua
Phone 00351 210 966 988
Email clinicalresearch@bioceramed.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety of the device are maintained until the reaching of its intended use in a commercial clinical setting in long bone and extremity defects.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 1, 2023
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities. - Give written informed consent to participate in the study and be willing to comply with the protocol requirements. - Able to verbalize and differentiate regarding the location and intensity of pain. - Physical and mental availability to meet the clinical and radiographic follow-up schedule. Exclusion Criteria: - Serious infection within two months before surgery. - Active malignancy, Cellulitis, Osteomyelitis, Osteomyelitis, Bone metastasis, Other bone metabolic diseases. - Primary bone tumors and contraindications in performing an X-ray or CTscan. - Women of childbearing potential who are, or plan to become, pregnant during the time of the study. - The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
bone graft substitute
Filling bone defects in current clinical practice

Locations

Country Name City State
Portugal Hospital Lusíadas Lisboa Lisboa

Sponsors (2)

Lead Sponsor Collaborator
Bioceramed Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological healing Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. 3 months
Primary Radiological healing Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. 6 months
Primary Radiological healing Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. 9 months
Primary Radiological healing Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. 12 months
Primary Radiological healing Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. 18 months
Primary Radiological healing Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST. 24 months
Secondary Number and description of any adverse event during the follow-up Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. 3 months
Secondary Number and description of any adverse event during the follow-up Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. 6 months
Secondary Number and description of any adverse event during the follow-up Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. 9 months
Secondary Number and description of any adverse event during the follow-up Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. 12 months
Secondary Number and description of any adverse event during the follow-up Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. 18 months
Secondary Number and description of any adverse event during the follow-up Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute. 24 months
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