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治験 NCT05744895（対象：変形性膝関節症）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
セントルイスのワシントン大学MAKO Total Knee Artroplasty
MAKO TKA patients will be given Fitbits and the Focus Motion Knee Brace to capture the data listed in attachment section. The results of this data will be compared to the control group to see if there is or there is not a difference in clinical outcomes with patients receiving Total knee surgery using the MAKO surgical robot versus those who got Total knee surgery without the MAKO robot.
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon knee system. Mean weekly VAS pain score during the first 4 weeks is the primary end point. Results of this study will be compared to prospective cohort of patients in the IRB study 201805014 from this institution who underwent TKA using non-robotic, manual instruments
Primary Hypothesis: Patients receiving robotic TKA will have better early recovery, including lower mean weekly VAS pain score for the first 4 weeks postoperatively and higher functional outcome scores, than the manual TKA historical cohort.
Secondary Hypothesis:
Patients receiving robotic TKA will have more accurate component position and alignment than the manual TKA historical cohort.
Potential Contribution: This study would give us a better understanding of the clinical and radiographic outcomes of patients receiving robotic TKA versus manual TKA. It will identify potential advantages and disadvantages of robotic TKA using the MAKO surgical robot.
Early Outcomes of Total Knee Arthroplasty Using the MAKO Surgical Robot and Triathlon Knee
- 202106145
| 参加グループ/群 | 介入/治療法 |
|---|---|
Prospective Group- Robotic TKA Arm Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine | Device: Robotic MAKO Total Knee Prospective TKA patient receiving total knee arthroplasty using the MAKO robotic machine Focusmotion Knee Brace Focusmotion knee brace measures range of motion during exercises Fitbit Tracking Device Fitbit will measure patients steps, HR, and sleep Focusmotion APP Will survey patients with PROMS |
Control- manual total Knee arthroplasty Patients who have had a manual total knee arthroplasty | 該当なし |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Early recovery | To determine if Robotic-arm assisted TKA (RA-TKA) allows for earlier recovery than manual TKA (MI-TKA). This will be measured by weekly VAS pain score.
\[Time Frame: 1 day- post op\] | 4 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Post op EOS measurements for alignment | To determine if Robotic-arm assisted TKA (RA-TKA) allows for more accurate component placement than manual TKA (MI-TKA). units of measurement will be inches. | 1 year |
- Planning to undergo Unilateral primary total knee arthroplasty
- 18 and up
- Willing to sign informed consent
- Willing to return for all follow-up visits
- Smartphone or tablet device capable of running the Fitbit andFocusMotion platform
- BMI > 45
- Inflammatory arthritis
- Narcotic use greater than 5 days per week
- Walking aid for musculoskeletal or neurologic issue other than operative joint
- Bilateral total knee arthroplasty
- Patient with an active infection or suspected infection in the operative joint
- The absolute and relative contraindications stated in the FDA cleared labeling for the device
セントルイスのワシントン大学476 件のアクティブな治験を探索Stryker NordicMissouri