The Clinical Therapeutic Effects and Safety of Tissue-engineered Bone

NCT02748343 | Unknown Phase 1

• 1 other identifier: bilong11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare use of a tissue-engineered bone to use of a standard allograft bone to treat bone defect in patients. The hypothesis is that use of the tissue-engineered bone is effective and safe to treat the bone defect in patients.

Conditions

Bone Defect; Bone Nonunion

Outcome Measures

Primary Outcomes (2)

• The scores of bone healing

  The scores of bone healing are divided into three kinds: nonhealing: 0; delayed healing: 1; normal healing: 2. The average score of tissue-engineered bone is compared with the score of control group using allograft bone to verify the clinical efficacy of tissue-engineered bone.

  within 48 weeks after surgical treatment of bone dect

• the adverse event incidence using tissue-engineered bone and allograft bone

  the adverse event incidence of tissue-engineered bone is compared with the adverse event incidence of allograft bone to verify the safety of tissue-engineered bone.

  within 24 weeks after surgical treatment of bone dect

Secondary Outcomes (12)

• The scores of blood routine test

  within 48 weeks after surgical treatment of bone dect

• The scores of erythrocyte sedimentation rate(ESR)

  within 48 weeks after surgical treatment of bone dect

• The scores of C-reactive protein

  within 48 weeks after surgical treatment of bone dect

• The scores of the ratio of complement C3 to complement C4

  within 48 weeks after surgical treatment of bone dect

• The scores of immunoglobulin assay

  within 48 weeks after surgical treatment of bone dect

Study Arms (2)

allograft bone

ACTIVE COMPARATOR

traditional allograft bone

Device: allograft bone

tissue-engineered bone

EXPERIMENTAL

tissue-engineered bone

Device: tissue-engineered bone

Interventions

allograft bone DEVICE

Use of the allograft bone to treat the bone defect in patients

allograft bone

tissue-engineered bone DEVICE

Use of the tissue-engineered bone to treat the bone defect in patients

tissue-engineered bone

Eligibility Criteria

• Age: 1 Year - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• the patients with bone defect and bone nonunion caused by tumor or trauma
• the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter
• the size of bone defect is more than 5cmx5cm
• the patients are unable to use autologous bone graft or other treatments
• the patients request to use the treatment of tissue-engineered bone
• Supportive family with willingness to participate in completing questionnaires

You may not qualify if:

• Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on.
• Patients who are pregnant
• Patients with serious abnormal cardiopulmonary function
• Patients disagree to use the tissue-engineered bone
• Patients are older than 60 years
• Patients who are regarded to be unqualified by investigator

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Orthopedics, Xijing Hospital, The Fourth Military Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

Central Study Contacts

long bi, MD,PHD

CONTACT

+86 02984773524; bilong@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: April 22, 2016
• Study Start: November 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2020
• Last Updated: November 17, 2017

Record last verified: 2017-03

Locations

CN (1)