Knee Arthritis Clinical Trial
Official title:
Alignment of Total Knee Components Using Standard or Custom Instrumentation
Verified date | May 2013 |
Source | VA Palo Alto Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The hypothesis of this study is that total knee alignment will be improved by preoperative planning from CT scans and the production of custom instruments compared to the use of standard instruments.
Status | Completed |
Enrollment | 64 |
Est. completion date | January 2013 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria:patients undergoing primary total knee replacement - Exclusion Criteria:patients who have hardware involving the hip, knee or ankle |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Palo Alto VA HCS | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Palo Alto Health Care System | DePuy Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alignment of Knee - Measured Mechanical Axis From CT Data | the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment | postoperatively - CT done within 1 week of surgery | No |
Secondary | Surgical Time | the difference between the average surgical time will be determined and compared with 95% CI | intraoperative surgical time | No |
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