Gonarthrosis Patients Who Need Artificial Knee Joint Total Replacement Clinical Trial
Official title:
Efficacy and Safety of Vanguard PS Knee Joint System Using MIS Technique
| NCT number | NCT01010828 |
| Other study ID # | JP12 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 1, 2009 |
| Est. completion date | March 31, 2012 |
| Verified date | March 2019 |
| Source | Zimmer Biomet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will show whether Tri-Vector method can ensure more extensive visual field and conduct the precise surgery when compared with Mini Mid-Vastus method by conducting 2 types of skin incision approach, Tri-Vector for 36 patients or Mini-Mid Vastus for 36 patients in Vanguard PS artificial knee joint total replacement observational period before and during surgery.
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | March 31, 2012 |
| Est. primary completion date | March 31, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - The patients who need artificial knee joint replacement in ordinary medical consultation are selected as the subjects. Exclusion Criteria: - Patients with infections such as osteomyelitis, or sepsis (Because the affected part is lesioned, excellent surgical results cannot be obtained.) |
| Country | Name | City | State |
|---|---|---|---|
| Japan | National Hospital Organization, Osaka National Hospital | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Zimmer Biomet | Biomet Japan, Inc. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Force from femoral and tibial side to retract and bring visual field into view | intraoperatively | ||
| Secondary | Incision length | intraoperatively | ||
| Secondary | Visual determination of the extension and flexion gap | intraoperatively |