Knee Arthritis Clinical Trial
| NCT number | NCT00982956 |
| Other study ID # | 2007023 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 22, 2009 |
| Last updated | September 22, 2009 |
| Verified date | September 2009 |
| Source | Chinese PLA General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Observational |
Objective:
The purpose of this study is to evaluate the application of computer-assisted navigation in
Total Knee Arthroplasty (TKA ) by comparing it with conventional TKA.
Methods:
Gemini MK II implants (Link, Germany) were used. VectorVisionâ CT-free navigation system
(BrainLab, Germany) was employed for the TKA. For each subject, computer-navigation TKA and
the conventional TKA were separately performed on two knee joints. The operative method and
order of the operations were decided on a randomized basis. All the patients and doctors
conducting follow-up study and performing imaging measurement were blind to selection of the
operation. Student t test was used for statistical analysis.
hypothesis: computer-assisted navigation system can significantly improve the accuracy of
tibial and femoral cuts on coronal and sagittal planes.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - plan for simultaneous bilateral TKA. Exclusion Criteria: - plan for unilateral TKA. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Chinese PLA General Hospital |
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