Knee Arthropathy
Conditions
Brief summary
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time.
Detailed description
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing Robotic Arm-Assisted TKA (RA-TKA) with the intraoperative use of a tourniquet to those undergoing RA-TKA with a short tourniquet time. The primary objectives will be to compare the total duration of hospital stay, quadriceps function, and the amount of postoperative narcotics utilized and VAS pain levels. The secondary objective will be to compare variables of patient functionality at five postoperative intervals.
Interventions
OTHERPrimary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time
Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.
OTHERPrimary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is over the age of 21 2. Patient is scheduled to undergo a unilateral, cementless primary RA-TKA, secondary to osteoarthritis 3. Surgical approach is subvastus approach 4. Patient's BMI (body mass index) is less than 40 at time of surgery. 5. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents 6. Patient is able to read and speak English
Exclusion criteria
1. Patient is under the age of 21 2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis) 3. Patient is scheduled to undergo a bilateral TKA surgery 4. Patient BMI is \> 40 5. Patient is unable to read and speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss (EBL) | outcome measure will be taken at 2 weeks postoperatively | Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc). |
| Knee Society Score | outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) | Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome. |
| WOMAC Score | outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) | WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome. |
| Active range-of-motion (ROM) | outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery) | Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees) |
| Amount of narcotic medication utilized | outcome measure will be taken 24 hours postoperatively | Amount of narcotic medication utilized (daily dosage measured as a Milligram Morphine Equivalent (MME) value). |
| Visual Analog Scale | outcome measure will be taken 24 hours postoperatively | The Visual Analog Scale measures the patient's level of knee pain on a scale of zero to ten via what the patient expresses verbally. The Visual Analog Scale (VAS) represents the degree of pain that the patient is experiencing at the time the measure is taken. Zero represents pain-free. A 10 would represent pain so excruciating as to warrant emergency medical assistance, or as it is described to the patient, the worst pain imaginable. Obviously, the lower the number, the better the outcome. There is no subscale. |
| Distance that patient is able to walk | outcome measure will be taken 24 hours postoperatively | Distance that patient is able to walk, as measured in feet |
| Ability to rise from a chair independently | outcome measure will be taken 24 hours postoperatively | Ability to rise from a chair independently (Yes/No) |
| Use of an ambulatory assistive device | outcome measure will be taken 24 hours postoperatively | Use of an ambulatory assistive device (Yes/No) |
| Return to driving | outcome measure will be taken 2 weeks (± 4 days) postoperatively | Return to driving (Yes/No) |
| Level of Patient Satisfaction: 5-point Likert scale | outcome measure will be taken at 6 weeks (± 2 weeks) postoperatively. | Level of Patient Satisfaction as measured using a 5-point Likert scale |
| Quadriceps Function | outcome measure will be taken at 2 weeks (± 4 days) | Quadriceps Function as measured in peak force in kilograms by a Hand-held dynamometer (model 01163; Lafayette Instrument Company, Lafayette, Ind., USA) |
| total length of hospital stay | outcome measure will be taken at 2 weeks postoperatively | total length of hospital stay as defined by number of days from date of surgery to date of discharge |
| Dates of postoperative exams | outcome measure will be taken at 2 weeks (± 4 days) postoperatively | Dates of postoperative exams as defined by dates that subject returns to the P.I.'s office for postoperative exam |
| Incidence of postop transfusion | outcome measure will be taken at 2 weeks postoperatively | Incidence of postop transfusion as defined by one or more transfusions of blood to the subject postoperatively |
| Change in creatinine level (CKMB) | outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two. | Change in CKMB (creatinine level) as defined by the CKMB values recorded in the participant's lab report |
| Change in hemoglobin level (HgB) | outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two. | Change in HgB as defined by the HgB values recorded in the participant's lab report |
| Operative Time | outcome measure will be taken at 2 weeks postoperatively | Total Operative Time as defined in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with postoperative complications | outcome measure will be taken at 1 year (± 2 months) postoperatively | Number of Participants with postoperative complications. A postoperative complication is defined as any diagnosis or condition that necessitates a re-operation on the surgical knee |
Countries
United States
Outcome results
None listed