The efficacy of tourniquet assisted total knee arthroplasty on patient-reported and performance-based physical function: a randomized controlled trial protocol

Abstract

BackgroundSurgical treatment of osteoarthritis with total knee arthroplasty (TKA) usually takes place in a complete bloodless field using a tourniquet. However, doing the surgery without a tourniquet may reduce muscle damage, post-surgery pain and led to improved functional rehabilitation and mobilization.Methods/DesignA prospective, blinded, parallel-group, controlled superiority trial, with balanced randomization [1:1]. Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology, Odense University Hospital, Denmark. A total of 80 patients will be randomly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms. The tourniquet assisted TKA group will have an automatic, micro-processor-based pneumatic tourniquet inflated around the thigh during surgery. The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet. The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function (KOOS-ADL). The secondary aim is to compare post-surgery pain, function in sports and recreation, quality of life, and performance-based physical function. The explorative outcomes include; use of pain medication, single-fiber muscle damage, and changes in mechanical muscle function. The primary endpoint will be at 3-months following surgical treatment, and the time-point for analysis of the primary outcome. However, follow-up will continue up to 1 year, and provide medium-term results. The treatment effect (difference in KOOS-ADL) will be analyzed using a random effects regression model, crude and adjusted results will be reported, if needed. Analyses will be based on the intention-to-treat (ITT). Subsequent per-protocol analysis may be necessary in the event of a substantial number of patients (> 15%) being lost during follow-up. The number needed to treat (NNT) for a positive effect of treatment (>10 points on KOOS-ADL) will be reported.DiscussionThis is the first randomized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures. As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee.Trial registrationClinicalTrials NCT01891266.

No clear benefit or drawback to the use of closed drainage after primary total knee arthroplasty: a systematic review and meta-analysis

“…However, this meta-analysis found no significant between-group differences in total or hidden blood loss, although the total blood loss was more, and the hidden blood loss was less, in the closed drainage group. Clinically, the postoperative bleeding is thought to occur during the early stage after surgery, and as a result, many studies have theorised that postoperative bleeding might be decreased by the temporary clamping of drains postoperatively [ 24 , 25 ], the use of a tourniquet intraoperatively [ 26 , 27 ], and/or intravenous and/or local use of tranexamic acid perioperatively [ 28 ], which is discussed below.…”

Comparing the Effects of Two Tourniquet Times on Pain and Knee Range of Motion after Internal Plate Fixation of Tibia Fractures

“…Cushing's inspiration for pneumatic tourniquet came from sphygmomanometer system. It is now more than a century that surgeons use pneumatic tourniquet to manage intraoperative bleeding [9].…”

“…On the other hand, electromyographic alterations in the quadriceps muscle were also reported after using tourniquet for knee surgeries [10]. In addition, Lohmann-Jensen et al reported that patients who underwent no-tourniquet total knee arthroplasty were able to start rehabilitation exercises faster than patients who received tourniquet-assisted total knee arthroplasty and thus, they were able to use their newly-transplanted knee more confidently, experienced fewer immobility-related complications, and expressed higher satisfaction with medical and care services [9].…”

The Impact of Tourniquet Release Time on Wound Healing in Patients Undergoing Tibia Fracture Plating Surgery

“…Pneumatic tourniquets, first proposed in 1904 by Cashing, contain cuffs, which encircle the limb and are inflated with compressed gas (3,4). Tourniquets have been used for a century by surgeons for operations on lower limbs, with higher pressure than systolic blood pressure (5).…”