Clinical trial NCT04645186: Calcium Phosphate Cement As Bone Void Filler
Official title: CALCIUM PHOSPHATE CEMENT AS BONE VOID FILLER - a Prospective Cohort Study in Patients Indicated for Long Bone and Extremity Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Defects
Lead sponsor: Bioceramed
Sponsor class: INDUSTRY
Collaborators: name: Universidade Nova de Lisboa
First posted: 2020-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is considered as all the patients included in the study that meet the inclusion and exclusion criteria.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Radiological healing
timeFrame: 3 months
measure: Radiological healing
timeFrame: 6 months
measure: Radiological healing
timeFrame: 9 months
measure: Radiological healing
timeFrame: 12 months
measure: Radiological healing
timeFrame: 18 months
measure: Radiological healing
timeFrame: 24 months
Secondary outcomes:
measure: Number and description of any adverse event during the follow-up
timeFrame: 3 months
measure: Number and description of any adverse event during the follow-up
timeFrame: 6 months
measure: Number and description of any adverse event during the follow-up
timeFrame: 9 months
measure: Number and description of any adverse event during the follow-up
timeFrame: 12 months
measure: Number and description of any adverse event during the follow-up
timeFrame: 18 months
measure: Number and description of any adverse event during the follow-up
timeFrame: 24 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital Lusíadas Lisboa
Study officials:
affiliation: Hospital Lusíadas Lisboa
name: Nuno A Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
References: