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Brainlabknee 3.2 navigation system in total knee arthroplasty for severe knee osteoarthritis: a prospective, double-blind, randomized controlled trial study

Brainlabknee 3.2 navigation system in total knee arthroplasty for severe knee osteoarthritis: a prospective, double-blind, randomized controlled trial study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065177
Enrollment
Unknown
Registered
2022-10-31
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

knee osteoarthritis

Interventions

intervention group:using the Brainlabknee 3.2 navigation system to undergo total knee arthroplasty
control group:Undergo the traditional total knee arthroplasty

Sponsors

Gansu Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The diagnostic criteria for KOA were met, all in patients who had their first unilateral TKA; 2. Staging and grading were in accordance with the diagnostic criteria for X-rays proposed by Kellgren and Lawrence in 1957, with a K-L grading of grade IV; 3. Progressive KOA with poor outcome through non-surgical treatment; 4. Clear clinical symptoms with joint pain, stiffness and marked restriction of functional activity.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of early KOA; 2. History of previous knee surgery; 3. Diagnosis or combination of knee tuberculosis, septic infection, and Charcot arthritis; 4. Combined coronal or sagittal deformity >= 20 degrees; 5. Poor physical condition of the patient, combined with other serious medical conditions; 6. Presence of significant contraindications to surgery and inability to tolerate surgery; 7. Mental abnormalities and inability to accept or cooperate with treatment.

Design outcomes

Primary

MeasureTime frame
Joint Function;Radiographic Parameters;

Secondary

MeasureTime frame
Surgical conditions;

Countries

China

Contacts

Public ContactXi-Ping Chai

Gansu Provincial Hospital of Chinese Medicine

chaixiping888@163.com+86 15009427352

Outcome results

None listed

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