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A prospective, non-interventional, multi-center clinical observational study of 3D printed porous cone for reconstructing knee bone defects

A prospective, non-interventional, multi-center clinical observational study of 3D printed porous cone for reconstructing knee bone defects

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055977
Enrollment
Unknown
Registered
2022-01-30
Start date
2022-01-26
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

knee osteoarthritis

Interventions

3 D printing group:3D printed porous cone

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Primary joint replacement is required for primary knee osteoarthritis, rheumatoid arthritis or traumatic arthritis, or revision knee replacement is required for various reasons; 2. Tibial or femoral bone defects of AORI classification TYPE II or above; 3. Unilateral joint replacement was performed; 4. Patients aged 18-85 years (including 18 and 85 years).

Exclusion criteria

Exclusion criteria: 1.History of the following diseases: renal insufficiency, liver insufficiency, severe heart disease, severe respiratory disease, coagulopathy, stroke, and malignant tumor; 2.Rheumatoid arthritis in active stage; 3.When the infection around the prosthesis is not completely controlled; 4.Patients with bone defects caused by bone tumors; 5.The patient has osteomalacia or any metabolic disorder that may impair bone formation; 6.Patients have allergies or suspected allergies to titanium implants; 7.Patients with immature bone development; 8.The patient is pregnant or breast-feeding or is a protected population (e.g. prisoner, mentally impaired, etc.).

Design outcomes

Primary

MeasureTime frame
failure rate;

Secondary

MeasureTime frame
Postoperative force line condition;Postoperative function;operation duration;

Countries

China

Contacts

Public ContactTian Hua

Peking University Third Hospital

tianhua@bjmu.edu.cn+86 13511065187

Outcome results

None listed

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