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A randomized controlled study on the safety and effectiveness of 3D printed personalized trabecular bioprostheses in knee-ankle replacement for Kashin-Beck disease

A randomized controlled study on the safety and effectiveness of 3D printed personalized trabecular bioprostheses in knee-ankle replacement for Kashin-Beck disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098038
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Kashin-Beck Disease

Interventions

Sponsors

Department of Orthopedics, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: After review and approval by the Medical Ethics Committee of West China Hospital of Sichuan University, patients with advanced knee and ankle osteoarthritis who meet the inclusion criteria and are accurately diagnosed by multi-radiomics and have failed to respond to conservative treatment are prospectively included and require joint replacement. 1) Unilateral total knee or ankle reconstruction under general anesthesia; 2) Patient/family member is informed and signs the informed consent form and is willing to participate in the study; 3) The preoperative American Society of Anesthesiologists classification (anesthesia risk assessment) is grade I-II.

Exclusion criteria

Exclusion criteria: 1) Those who cannot cooperate for various reasons; 2) Those who suffer from chronic pain or take analgesic drugs for a long time; 3) Patients with deep vein thrombosis of the affected limb, atherosclerotic plaque of the lower limb, and reduced arterial elasticity before surgery; 4) infection and revision; 5) Severe sleep disturbance or anxiety disorder (PSQI> 7 points); 6) Those who are allergic to or have adverse reactions to conventional analgesic drugs after surgery; 7) Patients with impaired renal or hepatic function.

Design outcomes

Primary

MeasureTime frame
Pain Visual Analog Scale;Joint mobility;12-Item Short Health Survey Score;American Knee Society Score (AKS);Functional Scoring for Adult Osteoarthropathy in Tibetan Areas;

Secondary

MeasureTime frame
Surgery time;Hospital Stay;Patient Satisfaction;30-day readmission;

Countries

China

Contacts

Public ContactZongke Zhou

West China School of Medicine and West China Hospital, Sichuan University

zhouzongke@scu.edu.cn+86 189 8060 1028

Outcome results

None listed

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