Bilateral Simultaneous Total Knee Arthroplasty for Bilateral Gonarthrosis
Condition: Bilateral Total Knee Arthroplasty; Gonarthrosis; Primary, Bilateral
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The effects of two-team and single-team simultaneous bilateral total knee arthroplasty (SBA)
      on peri- and postoperative complications are not clear. The investigators hypothesized that
      two-team SBA has lower early postoperative complication rates than single-surgeon SBA.
      Therefore, this prospective study compared minor and major complications for 90 days
      postoperatively between two-surgeon and single-surgeon SBA.
    

Detailed description: 
      Study Design:

      This prospective randomized study was approved by our institution's Clinical Research Ethics
      Committee (08.11.2017-71306642-050.01.04). The protocol conforms to CONSORT guidelines for
      parallel-group randomized trials and the protocol is designed to conform to the principles of
      the Declaration of Helsinki.

      Participant :

      The investigators will enroll 246 patients with primary bilateral symptomatic knee
      osteoarthritis that was refractory to conservative treatment who underwent bilateral TKA
      (total knee arthroplasty) under single anaesthesia between 2017 and 2018. An informed consent
      form will be obtained from all patients.

      The schedule for randomization was randomly generated using a computer before the initiation
      of the trial. Patients were randomly assigned in a 1:1 ratio. A blind medical staff member
      will organize the days of the surgeries of randomized patients for the two-surgeon (TS) or
      single-surgeon (SS) groups. Neither patients nor assessors will know about randomization
      results. The outcome assessor will be blinded to group allocation and will no involve in
      providing the interventions. The statistician performing the statistical analyses will be
      blinded to group allocation.

      Surgical procedures:

      All surgeries will be performed by two high-volume surgeons under regional or general
      anaesthesia. Both surgeons always will operate on the same side. Each of patients will
      receive a total knee prostheses-Vanguard (Zimmer Biomet,Inc, Warsaw, IN) - using a standard
      medial parapatellar approach without the use of a tourniquet. All patients will be given 2 g
      cefazolin for infection prophylaxis and 1 g tranexamic acid for blood loss prophylaxis
      intravenously 30 min before the incision. In the TS group, the two surgeons will start the
      incisions at the same time using two different instrumentation sets and with their own scrub
      nurses. In the SS group, the surgeon will operate on both knees consecutively. No Hemovac
      drains will be used in either group. After closing the joint capsule, 1 g tranexamic acid
      will be injected into the joint in both groups.

      All patients will start a standard physiotherapy program with the same blinded therapist. All
      patients will be started walking on the first postoperative day, using two crutches or a
      walker. Antibiotic prophylaxis will be continued for 24 h with 1 g intravenous cefazolin
      every 6 h. Venous thromboembolism prophylaxis will be administered using low-molecular-weight
      heparin for 4 weeks postoperatively. The investigators will check the estimated blood loss
      (EBL) on the first postoperative day. All patients will be asked to visit our outpatient
      clinic at 2 and 6 weeks and 3 months postoperatively. For functional outcomes and pain will
      be used the Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis
      Index (WOMAC), and a visual analog scale (VAS) preoperatively and 90 days postoperatively.

      Primary Outcome:

      The prespecified primary outcome was the between-group difference according to the rate of
      major complications.The investigators will assess major complications in all patients until
      90 days postoperatively.

      Secondary Outcomes:

      The investigators also will assess the estimated blood loss (EBL), minor complications,
      operation time and functional results among the groups. The EBL will be calculated using the
      Gross formula and compared between the groups.

      Statistical methods:

      Categorical variables will be analyzed using the chi-square test and continuous variables
      will be tested using the Mann-Whitney U-test. The statistical analyses will be performed
      using IBM SPSS Statistics for Windows, ver. 22.0. (IBM, Armonk, NY). Significance was set at
      α < 0.05.
    

Intervention name(s): Two-team simultaneous bilateral total knee arthroplasty; Single-team simultaneous bilateral total knee arthroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Bilateral total knee arthroplasty can be performed in three different ways: single-stage, two-team simultaneous bilateral total knee arthroplasty; single-stage, one-surgeon, and two-stage bilateral total knee arthroplasty. Two surgeons will operate simultaneously on one side for two-team SBA.; One surgeon will operate sequentially on both sides for one-surgeon SBA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; complication; safety; operative time