Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Patients will be randomized to have either customized knee instruments or standard generic instrumentation for primary total knee replacement. Postoperative CT scan will be used to determine alignment of each group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator | control group will have standard instrumentation of their knee replacement |
|
| trumatch group | Experimental | the trumatch patient will have custom instruments made from preop CT scans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trumatch group | Procedure | these patient will have CT based customized knee instruments used for surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Time | the difference between the average surgical time will be determined and compared with 95% CI | intraoperative surgical time |
Not provided
Inclusion Criteria:patients undergoing primary total knee replacement -
Exclusion Criteria:patients who have hardware involving the hip, knee or ankle
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto VA HCS | Palo Alto | California | 94304 | United States |
1 participant was excluded because withdrew prior to assignment
Participants were recruited from 6-2010 thru 6-2011 at the VA Palo Alto HCS
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trumatch Group | trumatch group will have customized knee instruments : CT based customized knee instruments |
| FG001 | Control Group | control group will have standard instrumentation of their knee replacement |
| FG002 | Both Interventions | one participant had both interventions - one for each knee |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement study group will have customized knee instruments : CT based customized knee instruments |
| BG001 | Trumatch Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Surgical Time | the difference between the average surgical time will be determined and compared with 95% CI | particpants who completed study | Posted | Mean | 95% Confidence Interval | delta between means in minutes | intraoperative surgical time |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement study group will have customized knee instruments : CT based customized knee instruments |
Not provided
Not provided
none except small sample sizes
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven T Woolson, MD | VA Palo Alto HCS | 650-493-5000 | 66101 | steven.woolson@va.gov |
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| control group | Procedure | these patients will have standard instrumentation used for for knee replacement |
|
|
patients randomized to study instrumentation |
| BG002 | Both Interventions | one participant had bilateral knee replacement with one control knee and one trumatch knee |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| knee replacement participant | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | all participants who completed the study | Posted | Mean | 95% Confidence Interval | degrees | postoperatively - CT done within 1 week of surgery |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Trumatch Group | patients randomized to study instrumentation | 0 | 22 | 0 | 22 |
Not provided
Not provided
| D008722 | Methods |