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Comparison of a novel handheld accelerometer-based navigation system, i-JOIN and conventional instrument for performing distal femoral resection in total knee arthroplasty: a prospective multi-center, double-blinded, randomized controlled trial

rforming distal femoral resection in total knee arthroplasty: a prospective multi-center, double-blinded, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023608
Enrollment
Unknown
Registered
2019-06-04
Start date
2017-07-01
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Osteoarthritis

Interventions

experimental group:knee navigation system, i-JOIN
control group:traditional instrument

Sponsors

The Drum Tower Hospital Affiliated to the Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Informed consent has been signed; 2) Patient aged ranged 18 to 80 years; 3) Total knee arthroplasty is required for knee lesions without implant contraindications; 4) The heart, liver and kidney function are good after clinical and laboratory examination; 5) Good compliance, willing and able to conduct follow-up observation as required.

Exclusion criteria

Exclusion criteria: 1. Participated in other medical device tests within 3 months; 2. Severe allergy; 3. Through direct inquiry and physical examination, there is evidence that the subjects have poor heart, liver and kidney function; 4. Poor compliance, mental disorder, difficult to cooperate; 5. Women during lactation or pregnancy; 6. For any reason, the researcher believes that the subject is unable to complete this study; 7. Evidence of drug abuse; 8. Patients with mental illness or serious heart disease; 9. Severe osteoporosis; 10. participants were considered unsuitable by the researchers.

Design outcomes

Primary

MeasureTime frame
The outlier of the whole limb mechanical axis ;

Secondary

MeasureTime frame
The coronal alignment of the femoral component;Knee Society Clinical Score (KSCS) and Knee Society Function Score (KSFS);

Countries

China

Contacts

Public ContactQing Jiang

The Drum Tower Hospital Affiliated to the Medical School of Nanjing University

jiangqing112@hotmail.com+86 13605192953

Outcome results

None listed

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