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Safety and efficacy of disposable sterile sheath guard saw blades in total knee arthroplasty: a prospective parallel controlled clinical study

Safety and efficacy of disposable sterile sheath guard saw blades in total knee arthroplasty: a prospective parallel controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098681
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-03-31
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

total knee arthroplasty

Interventions

Test group:Use disposable sterile sheath guard saw blade
Control group:Use disposable sterile bone saw blade

Sponsors

Hebei Medical University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age range of 50-75 years old (including threshold), regardless of gender; 2.Patients who require total knee arthroplasty (TKA) for the first time; 3.Voluntarily participate in clinical trials and sign an informed consent form before the start of the trial;

Exclusion criteria

Exclusion criteria: 1.Researchers have determined that there are surgical contraindications, such as severe systemic diseases (severe heart disease, respiratory system disease, coagulation dysfunction or undergoing anticoagulant therapy, acute systemic inflammation stage, etc.), and those who cannot tolerate anesthesia; 2.Merge severe osteoporosis, metabolic bone disease, and radiation bone disease; 3.Individuals with local or systemic infections of the knee joint; 4.Patients undergoing TKA for acute reasons, such as fractures or injuries; 5.Individuals with cognitive impairment or abnormal mental state who are unable to provide informed consent; 6.Other situations deemed unsuitable by researchers to participate in the study;

Design outcomes

Primary

MeasureTime frame
Depth of thermal injury on the osteotomy surface (distal femur, tibial plateau);

Secondary

MeasureTime frame
Time to completion of osteotomy;Osteotomy flatness;The highest temperature in the osteotomy facebook;Performance score;Pain VAS score;Postoperative complication rate;

Countries

China

Contacts

Public ContactYingze Zhang

Hebei Medical University Third Hospital

yzling_liu@163.com+86 18533112888

Outcome results

None listed

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