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Robot-assisted control study of early clinical results of functional alignment and mechanical axis alignment for total knee arthroplasty: a prospective double-blind randomized controlled trial

Robot-assisted control study of early clinical results of functional alignment and mechanical axis alignment for total knee arthroplasty: a prospective double-blind randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049679
Enrollment
Unknown
Registered
2021-08-08
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Knee osteoarthritis

Interventions

Control group:Robot-assisted total knee arthroplasty with mechanical alignment
Experimental group:Functional alignment robot-assisted total knee arthroplasty

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The initial diagnosis is primary unilateral knee joint disease, and there are indications for TKA surgery. 2. Able to accept robotic preoperative CT examination. 3. Aged between 18 and 80 years. 4. Agree to participate in the research.

Exclusion criteria

Exclusion criteria: 1. There is a history of osteotomy and infection in the past. 2. Patients considering the use of restrictive prostheses due to various factors such as joint instability and severe bone defects. 3. Severe flexion contracture (>20°). 4. Patients with septic arthritis requiring secondary surgery. 5. History of major surgical trauma to the ipsilateral limb within one year. 6. Knee valgus deformity.

Design outcomes

Primary

MeasureTime frame
Satisfaction;

Secondary

MeasureTime frame
Knee injury and osteoarthritis score;Forgotten joint score;Knee society score;Knee range of motion;Lower limb force line;

Countries

China

Contacts

Public ContactZhang Xianlong

Shanghai Sixth People's Hospital

2085785830@qq.com+86 18930177324

Outcome results

None listed

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