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A prospective, multicenter, randomized, parallel controlled, non inferior clinical trial to evaluate the effectiveness and safety of absorbable artificial bone in the repair of bone defects in limbs

A prospective, multicenter, randomized, parallel controlled, non inferior clinical trial to evaluate the effectiveness and safety of absorbable artificial bone in the repair of bone defects in limbs

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050827
Enrollment
Unknown
Registered
2021-09-04
Start date
2022-02-01
Completion date
Unknown
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone defect

Interventions

Experimental group:Absorbable artificial bone
Control group:Allogeneic bone implant materials

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, male or female; 2. Patients who were clinically diagnosed as limb bone defects and needed bone defect repair; 3. Patients who voluntarily participate and sign informed consent and participate in clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with mental disorders or unable to understand the requirements for participation in the study; 2. Subjects with poor expected compliance; 3. Known to have a history of allergy to one or more implant materials; 4. Patients with hemorrhagic diseases; 5. Patients with severe cardiopulmonary and other systemic diseases who the researchers believe cannot tolerate the operation; 6. Local or systemic active infection lesions; 7. Pregnant or lactating women; 8. Patients with long-term hormone use, mental illness, drug abuse or alcoholism; 9. Critical patients such as advanced tumors; 10. Fasting blood glucose was more than 8.0 mol/L in patients with diabetes mellitus; 11. Patients who have participated in clinical trials within 3 months; 12. The investigator believes that other reasons are not suitable for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Bone graft fusion rate;

Secondary

MeasureTime frame
Bone defect healing rate ;Quality of life of subjects;Product performance evaluation;

Countries

China

Contacts

Public ContactZhao Jinzhong

Shanghai Sixth People's Hospital

zhaojinzhong@vip.163.com+86 18930177160

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026