Navigated EM Total Knee Replacement: Accuracy Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Total Knee Replacement |
Procedure: computer-assisted surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Phase 2 Study of Computer Assisted Surgery vs Conservative Surgery- Accuracy Study. |
| Estimated Enrollment: | 200 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
navigation technique
|
Procedure: computer-assisted surgery |
|
B
conservative surgery
|
Procedure: computer-assisted surgery |
|
C
Historical control
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
men and women that are candidates for total knee replacement.
Inclusion Criteria:
- Signing informed consent
Exclusion Criteria:
- Pregnancy
- Soldiers in active military service
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00512421 History of Changes |
| Other Study ID Numbers: | LIB002-HMO-CTIL |
| Study First Received: | August 5, 2007 |
| Last Updated: | September 15, 2011 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
ClinicalTrials.gov processed this record on June 18, 2013