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Navigated EM Total Knee Replacement: Accuracy Study

H

Hadassah Medical Center

Status

Terminated

Conditions

Total Knee Replacement

Treatments

Procedure: computer-assisted surgery

Study type

Observational

Funder types

Other

Identifiers

NCT00512421
LIB002-HMO-CTIL

Details and patient eligibility

About

The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty.

The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques.

It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques.

Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology.

In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signing informed consent

Exclusion criteria

  • Pregnancy
  • Soldiers in active military service

Trial design

200 participants in 3 patient groups

A
Description:
navigation technique
Treatment:
Procedure: computer-assisted surgery
B
Description:
conservative surgery
Treatment:
Procedure: computer-assisted surgery
C
Description:
Historical control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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