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A multicenter, randomized, open-label, parallel-controlled clinical trial to evaluate the clinical application effectiveness and safety of the knee joint replacement surgery assistance system / SSFZXT-GSYH

A multicenter, randomized, open-label, parallel-controlled clinical trial to evaluate the clinical application effectiveness and safety of the knee joint replacement surgery assistance system / SSFZXT-GSYH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105793
Enrollment
Unknown
Registered
2025-07-10
Start date
2020-11-16
Completion date
Unknown
Last updated
2025-07-14

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

Conditions

Osteoarthritis

Interventions

experimental group:Perform robot-assisted total knee arthroplasty
control group:Perform conventional manual total knee arthroplasty

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age range: 50 - 80 years old, gender not restricted; (2) Patients diagnosed with end-stage knee joint diseases for which conservative treatment has been ineffective; (3) Patients assessed by the researchers as requiring the first unilateral knee joint replacement surgery; (4) Subjects/their guardians can understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and are willing to participate in this study and sign the Informed Consent Form (ICF).

Exclusion criteria

Exclusion criteria: (1) Neuromuscular dysfunction (such as paralysis, myolysis) can cause postoperative functional disorders that affect the function of the lower limbs; (2) Patients with severe internal or surgical diseases or weak constitution who cannot tolerate surgery; (3) Charcot joint; (4) Presence of active infection foci in the body (infection lesions exist both locally and throughout the body); (5) Severe osteoporosis, metabolic bone disease, radiation-induced bone disease, or tumors around the knee joint; (6) Patients with poor compliance; (7) Pregnant or lactating women, or patients with reproductive plans during the clinical study; (8) Other situations that the researcher deems unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Radiological analysis;Bone cutting deviation;haematological index;Segmental surgery time;General outcome;

Secondary

MeasureTime frame
Outcome measurement indicators reported by researchers and patients;Adverse events and complications;

Countries

China

Contacts

Public ContactYuan Zhang

The Second Affiliated Hospital of Army Medical University

zhangyuan@tmmu.edu.cn+86 23 6877 4082

Outcome results

None listed

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