Calcium Phosphate Cement As Bone Void Filler

Terminated

• Conditions: Bone Defects
• Interventions: Device: bone graft substitute

• Registration Number: NCT04645186
• Lead Sponsor: Bioceramed

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-05
• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-27
• Status Verified: 2024-11
• Primary Completion: 2024-11-06
• Study Completion: 2024-11-06
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Calcium Phosphate Cement (CPC)	bone graft substitute	Evaluation of CPC in long bone \& extremities

Primary Outcome Measures

Name	Time	Method
Radiological healing	24 months	Bone healing observable by x-ray/CT-scan. Assessment of trabecular defects: modified Neer classification. Assessment of cortical defects: modified RUST.

Secondary Outcome Measures

Name	Time	Method
Number and description of any adverse event during the follow-up	24 months	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.

Trial Locations

Locations (1)

Hospital Lusíadas Lisboa; 🇵🇹 Lisboa, Portugal