Blood Loss Assessment in the Limited Application of Tourniquet During Primary Unilateral TKA
Condition: Arthritis Knee; Blood Loss; Arthroplasty Complications
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Tourniquet application in total knee arthroplasty has many benefits and might have a role in
      the incidence of peri-operative complications the aim of this research: is to look into the
      effectiveness of the limited application of tourniquet during primary unilateral total knee
      arthroplasty and compare the perioperative complications with the standard full-time
      application.
    

Detailed description: 
      Tourniquet application has been a routine choice for most joint surgeons around the world,
      reducing intra-operative blood loss and the better clearance of the surgical field and the
      better cementation technique with a blood-free cancellous bone are the main benefits, while
      the possible negatives are the pain of the thigh, skin burns, neurovascular complications and
      possibly increased risk of VTE, and the literature states a new orientation towards reducing
      the time of application of tourniquet or even eliminating it, favoring avoiding its risks
      rather than captivating its benefits so the investigator conducted a prospective randomized
      double-blinded controlled study, and enrolled 62 patients between the beginning of 2021 and
      august,2022.

      after obtaining informed consent and approval by the institutional review board, the study
      was done in Damascus Syria, the investigator followed up every patient for six months,
      Participants were randomly assigned following simple randomization procedures (computerized
      random numbers) to 1 of 2 treatment groups, and the allocation was put into concealed
      envelopes independent of the surgeon and the author and the randomization was performed by a
      research fellow who was not involved in patient care, the tourniquet was applicated around
      the proximal thigh in all patients, the first group went unilateral primary TKA with
      inflating the tourniquet prior to incision and releasing it after closure and compression
      bandage application, while the second group went primary unilateral TKA with the tourniquet
      inflated only during cementation and final components application, the procedures were done
      under general, spinal or regional anesthesia based on the anesthetist consultant, a
      based-on-weight tranexamic acid dose was given intravenously before incision, all procedures
      was done by the same surgeon using the medial para-patellar approach , and the protheses used
      in all patients were cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing
      of the patella, intramedullary guides were uses for the femoral and tibial cuts, the patients
      were blinded to the intervention during the whole period of the study, while the surgeon and
      the author were unblinded by opening the envelope by a research member just before initiating
      anesthesia
    

Intervention name(s): primary unilateral total knee arthroplasty with limited application of tourniquet; primary unilateral total knee arthroplasty with full application of tourniquet
Intervention type(s): Procedure; Procedure
Intervention description(s): the tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be cruciate scarifying cemented DePuy Synthes PFC Sigma without resurfacing of the patella, intramedullary guides will be used for the femoral and tibial cuts as seen appropriate by the surgeon, however, the application time of the tourniquet during surgery will be as the allocation of each patient imply.; the tourniquet will be applicated around the proximal thigh in all patients before the incision, all patients will undergo primary unilateral TKA by the same surgeon using the medial para-patellar approach, and the prostheses used in all patients will be
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; blood loss; tourniquet; complications