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| Name | Class |
|---|---|
| Exactech | INDUSTRY |
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Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison Group: TKA patients whose surgery was conducted with traditional, manual instrumentation | Active Comparator | The comparison groups includes TKA patients whose surgery is conducted using traditional, manual, non-navigated instrumentation. |
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| Intervention Group: Patients whose TKA surgery was conducted using Exactech GPS navigation | Experimental | The intervention group will include TKA patients whose surgery is conducted with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKA using computer navigation | Device | TKA using Exactech GPS Newton Knee protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with TKA using patient reported KOOS JR Questionnaire | The KOOS, JR combines the pain, symptoms, and functional limitations into a single score. | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op |
| Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire | The OKS is a patient reported questionnaire that measures function and pain with a single score. | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op |
| Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire | The Forgotten Joint Score assesses the ability of the patient to forget about their joint given successful treatment by assigning a single score to a series of questions. | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op |
| Patient recovery from TKA using time from hospital stay to discharge | The time of in-patient hospital stay will be measured (in hours). | Post-op measure in hours |
| Patient recovery from TKA by measuring number of outpatient visits | Number of outpatient visits (scheduled and unscheduled) | One year post-op |
| Patient recovery from TKA by measuring number of PT visits | Number of post-op PT visits | One year post-op |
| Patient recovery from TKA by measuring medication consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Knee alignment and soft tissue balance | Telemetric x-rays will be used to assess the angles and evaluate the joint line status pre- and post-operatively. | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op |
| Knee alignment and soft tissue balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaplan Joint Center, Newton Wellesley Hospital | Newton | Massachusetts | 02468 | United States |
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| TKA | Procedure | TKA using manual instrumentation |
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Post-op, prescription medication will be recorded in number of pills and dosage
| One year post-op |
| Patient recovery from TKA by measuring use of assisted walking devices | Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery. | One year post-op |
Patients receiving a TKA NewtonTM Knee, soft-tissue balance will be measured intra-operatively by placing the Newton distractor at the trial reduction stage and acquiring the corresponding joint laxities through the arc of motion. |
| One time (during surgery) |