Calcium Phosphate Cement As Bone Void Filler

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-05

Study Completion Date

2024-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Defects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Calcium Phosphate Cement (CPC)

Evaluation of CPC in long bone \& extremities

bone graft substitute

Intervention Type DEVICE

Filling bone defects in current clinical practice

Interventions

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bone graft substitute

Filling bone defects in current clinical practice

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No