Calcium Phosphate Cement As Bone Void Filler

Bioceramed

Status

Terminated

Conditions

Bone Defects

Treatments

Device: bone graft substitute

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04645186

2019.04

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.