Calcium Phosphate Cement as Bone Void Filler

Bone Defects Clinical Trial

Official title:

CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645186
• Other study ID #: 2019.04
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Bone Defects

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