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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | computer-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.