Tourniquet vs. Short Time Tourniquet in Primary Robotic Assisted TKA

University of Louisville (UOFL)

Status: Completed

Conditions: Knee Arthropathy

Treatments: Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time; Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT03942939

19.0365

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

A - TKA with short tourniquet time

Experimental group

Description:

50 arms: subjects will receive a tourniquet with a short tourniquet time during TKA surgery. 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.

Treatment:

Other: Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time

B - TKA with tourniquet

Active Comparator group

Description:

50 arms: subjects will receive a tourniquet during TKA surgery.

Treatment:

Other: Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet