Clinical trial NCT03942939: Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA
Official title: Is TKA With Short Tourniquet Time Superior to TKA With Tourniquet Use in Primary Robotic Assisted TKA? A Prospective, Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
measure: Knee Society Score
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Knee Society Score
timeFrame: outcome measure will be taken 1 year (± 2 months) postoperatively
measure: WOMAC Score
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
measure: WOMAC Score
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: WOMAC Score
timeFrame: outcome measure will be taken 1 year (± 2 months) postoperatively
measure: Active range-of-motion (ROM)
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
measure: Active range-of-motion (ROM)
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Active range-of-motion (ROM)
timeFrame: outcome measure will be taken 1 year (± 2 months) postoperatively
measure: Amount of narcotic medication utilized
timeFrame: outcome measure will be taken 24 hours postoperatively
measure: Amount of narcotic medication utilized
timeFrame: outcome measure will be taken 48 hours postoperatively
measure: Amount of narcotic medication utilized
timeFrame: outcome measure will be taken 72 hours postoperatively
measure: Amount of narcotic medication utilized
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
measure: Amount of narcotic medication utilized
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Visual Analog Scale
timeFrame: outcome measure will be taken 24 hours postoperatively
measure: Visual Analog Scale
timeFrame: outcome measure will be taken 48 hours postoperatively
measure: Visual Analog Scale
timeFrame: outcome measure will be taken 72 hours postoperatively
measure: Visual Analog Scale
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
measure: Visual Analog Scale
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Distance that patient is able to walk
timeFrame: outcome measure will be taken 24 hours postoperatively
measure: Distance that patient is able to walk
timeFrame: outcome measure will be taken 48 hours postoperatively
measure: Distance that patient is able to walk
timeFrame: outcome measure will be taken 72 hours postoperatively
measure: Distance that patient is able to walk
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
measure: Distance that patient is able to walk
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Ability to rise from a chair independently
timeFrame: outcome measure will be taken 24 hours postoperatively
measure: Ability to rise from a chair independently
timeFrame: outcome measure will be taken 48 hours postoperatively
measure: Ability to rise from a chair independently
timeFrame: outcome measure will be taken 72 hours postoperatively
measure: Ability to rise from a chair independently
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
measure: Ability to rise from a chair independently
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Use of an ambulatory assistive device
timeFrame: outcome measure will be taken 24 hours postoperatively
measure: Use of an ambulatory assistive device
timeFrame: outcome measure will be taken 48 hours postoperatively
measure: Use of an ambulatory assistive device
timeFrame: outcome measure will be taken 72 hours postoperatively
measure: Use of an ambulatory assistive device
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
measure: Use of an ambulatory assistive device
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Return to driving
timeFrame: outcome measure will be taken 2 weeks (± 4 days) postoperatively
measure: Return to driving
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Level of Patient Satisfaction: 5-point Likert scale
timeFrame: outcome measure will be taken at 6 weeks (± 2 weeks) postoperatively.
measure: Level of Patient Satisfaction: 5-point Likert scale
timeFrame: outcome measure will be taken 1 year (± 2 months) postoperatively
measure: Quadriceps Function
timeFrame: outcome measure will be taken at 2 weeks (± 4 days)
measure: Quadriceps Function
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Quadriceps Function
timeFrame: outcome measure will be taken 1 year (± 2 months) postoperatively
measure: total length of hospital stay
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Dates of postoperative exams
timeFrame: outcome measure will be taken at 2 weeks (± 4 days) postoperatively
measure: Dates of postoperative exams
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Dates of postoperative exams
timeFrame: outcome measure will be taken 1 year (± 2 months) postoperatively
measure: Incidence of postop transfusion
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Change in creatinine level (CKMB)
timeFrame: outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
measure: Change in hemoglobin level (HgB)
timeFrame: outcome measures will be taken preoperatively (4-6 weeks prior to date of surgery) and on postoperative day number two.
measure: Operative Time
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Estimated Blood Loss (EBL)
timeFrame: outcome measure will be taken at 2 weeks postoperatively
Secondary outcomes:
measure: Number of Participants with postoperative complications
timeFrame: outcome measure will be taken at 1 year (± 2 months) postoperatively
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Arthur L Malkani, MD
role: PRINCIPAL_INVESTIGATOR
References: