Clinical Trials Directory

Trials / Terminated

TerminatedNCT00512421

Navigated EM Total Knee Replacement: Accuracy Study

Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study.

Status
Terminated
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Hadassah Medical Organization · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcomputer-assisted surgery

Timeline

First posted
2007-08-07
Last updated
2011-09-16

Locations

1 site across 1 country: Israel

Source: ClinicalTrials.gov record NCT00512421. Inclusion in this directory is not an endorsement.