Knee Arthritis
Conditions
Keywords
alignment
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREtrumatch group
these patient will have CT based customized knee instruments used for surgery
PROCEDUREcontrol group
these patients will have standard instrumentation used for for knee replacement
Sponsors
DePuy Orthopaedics
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
patients undergoing primary total knee replacement -
Exclusion criteria
patients who have hardware involving the hip, knee or ankle \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alignment of Knee - Measured Mechanical Axis From CT Data | postoperatively - CT done within 1 week of surgery | the mean knee mechanical axis was determined from 3D CT data - negative value designates varus alignment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Time | intraoperative surgical time | the difference between the average surgical time will be determined and compared with 95% CI |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 6-2010 thru 6-2011 at the VA Palo Alto HCS
Pre-assignment details
1 participant was excluded because withdrew prior to assignment
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| Trumatch Group patients randomized to study instrumentation | 30 |
| Both Interventions one participant had bilateral knee replacement with one control knee and one trumatch knee | 1 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | medically unable to have surgery | 4 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 |
Baseline characteristics
| Characteristic | Control | Trumatch Group | Both Interventions | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 11 Participants | 1 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 0 Participants | 39 Participants |
| Age Continuous | 65.1 years STANDARD_DEVIATION 8.3 | 67.3 years STANDARD_DEVIATION 7.7 | 81 years STANDARD_DEVIATION 0 | 66.1 years STANDARD_DEVIATION 7.9 |
| knee replacement participant | 33 participants | 30 participants | 1 participants | 64 participants |
| Region of Enrollment United States | 33 participants | 30 participants | 1 participants | 64 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 33 Participants | 30 Participants | 1 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 22 |
| serious Total, serious adverse events | 0 / 26 | 0 / 22 |
Outcome results
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
Time frame: postoperatively - CT done within 1 week of surgery
Population: all participants who completed the study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Alignment of Knee - Measured Mechanical Axis From CT Data | -1.7 degrees |
| Trumatch Group | Alignment of Knee - Measured Mechanical Axis From CT Data | -1.3 degrees |
Secondary
Surgical Time
the difference between the average surgical time will be determined and compared with 95% CI
Time frame: intraoperative surgical time
Population: particpants who completed study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | Surgical Time | 4.0 delta between means in minutes |
| Trumatch Group | Surgical Time | 0 delta between means in minutes |