Clinical study on custom-made bone implants alpha-TCP-based novel bone implants with geometry that fits bone defects and internal structures efficient for bone tissue regeneratio

Not Applicable

• Conditions: Congenital, traumatic, post-operative or tumorous defects/deformations of unloaded bones in cranio-maxillofacial areas and limbs and trunks

• Registration Number: JPRN-UMIN000000605
• Lead Sponsor: The University of Tokyo Hospital Division of Tissue Engineering

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-09
• Study Completion: 2008-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with complications including abnormal calcium metabolism or serious cardiac, hepatic or renal dysfunctions (grade 2 and grade 3 in the complication category) 2) Patients who have less-than-one-year prognoses of complications 3) Patients with severe complications who are not expected to endure tests necessary for clinical follow-up. 4) Patients with infections that may relapse. 5) Patients with collagen diseases. 6) Patients with histories of alcohol or drug dependency within the past 3 months 7) Patients with malignant neoplasms 8) Patients with possibile malignant neoplasms 9) Patients with proliferative diabetic retinopathy 10) Pregnant women, women suspected of being pregnant and breast-feeding women 11) Patients who cannot observe the instruction not to inflict excessive forces and burdens on affected areas after implantation and patients with mental disorders. 12) Patients who do not give informed consents 13) Patients who are judged to be inappropriate for the study by doctors in charge.

Study & Design

• Study Type: Interventional
• Study Design: Not specified