Total Knee Arthroplasty
Conditions
Brief summary
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
Detailed description
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®).
Interventions
DEVICETKA using computer navigation
TKA using Exactech GPS Newton Knee protocol
PROCEDURETKA
TKA using manual instrumentation
Sponsors
Exactech
Newton-Wellesley Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of Kaplan Joint Center, Newton Wellesley Hospital scheduled for TKA with a specific implant
Exclusion criteria
* Patients may be excluded due to some medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient recovery from TKA by measuring use of assisted walking devices | One year post-op | Patient recovery from TKA by measuring the number of days using an assisted walking device following surgery. |
| Patient satisfaction with TKA using patient reported KOOS JR Questionnaire | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op | The KOOS, JR combines the pain, symptoms, and functional limitations into a single score. |
| Patient satisfaction with TKA using Oxford Knee Score (OKS) Questionnaire | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op | The OKS is a patient reported questionnaire that measures function and pain with a single score. |
| Patient satisfaction with TKA using Forgotten Joint Score (FJS) Questionnaire | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op | 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. |
| Patient recovery from TKA using time from hospital stay to discharge | Post-op measure in hours | The time of in-patient hospital stay will be measured (in hours). |
| Patient recovery from TKA by measuring number of outpatient visits | One year post-op | Number of outpatient visits (scheduled and unscheduled) |
| Patient recovery from TKA by measuring number of PT visits | One year post-op | Number of post-op PT visits |
| Patient recovery from TKA by measuring medication consumption | One year post-op | Post-op, prescription medication will be recorded in number of pills and dosage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee alignment and soft tissue balance | Pre-op, 4 weeks post-op, 12 weeks post-op, one year post-op | Telemetric x-rays will be used to assess the angles and evaluate the joint line status pre- and post-operatively. |
Countries
United States
Outcome results
None listed