The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty
Condition: Wound; Knee
Study type: Interventional

Summary: 
      The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control
      suture device is a barbed suture that uses anchor technology to securely engage with the soft
      tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of
      the device core or formed within the core in a geometric pattern and arranged in a tapered
      manner to allow the device to pass through tissue in the direction toward the needle during
      closure. These knotless tissue control devices are deployed using a continuous technique,
      which is anticipated to be faster and more cost-effective than interrupted suturing.
    

Detailed description: 
      Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and deep
      tissue closures.[1], [2] In addition, barbed sutures have been shown to provide water-tight
      closure and wound strength comparable to or superior to closure with conventional sutures.
      Many comparative studies have been published contrasting barbed sutures to conventional
      closure techniques in multiple surgical fields. [3], [4] Various studies have evaluated the
      outcomes of different barbed suture devices, however there are no reports assessing the
      length of closure times using STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New
      Jersey) Knotless Tissue Control Devices during deep closure in total hip arthroplasty.
      Stephens et al. [5] performed a prospective randomized study of 500 total knee arthroplasty
      patients who received either barbed suture (250) or conventional sutures (250) for deep
      closure of the surgical wound. The mean operating time was significantly shorter in the
      barbed group as compared to conventional group (64.3 vs 68.1 minutes, p=<0.001). In a study
      of 80 TKA (61 barbed, 19 conventional deep sutures) and 54 THA patients (37 barbed, 17
      conventional deep sutures), Smith et al. [6] found significantly shorter closure time in the
      barbed suture group (16.78 vs. 26.5 minutes, p<0.001). One study reports one the use of
      Stratfix suture for intracorporeal suturing in myomectomy. Giampaolino et al. [7] performed a
      prospective randomized study on 47 patients and evaluated the mean operative time for
      laparoscopic posterior myomectomy using Stratafix or conventional suture for intracorporeal
      suturing. There was a significant decrease in mean operative time associated with use of
      Stratafix suture as compared to conventional suture (66.3 vs 73 minutes, p=0.005).

      This prospective randomized single-center study will examine the outcomes, mainly closure
      time, of deep closure during total knee arthroplasty using the STRATAFIX Symmetric PDS Plus
      (Ethicon, Johnson and Johnson, Somerville, New Jersey) barbed suture compared to interrupted
      VICRYL suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).
    

Intervention name(s): STRATIFIX; VICRYL
Intervention type(s): Device; Device
Intervention description(s): STRATIFIX symmetric PDS Plus; Stratifix knotless suture; Vicryl #1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: barbed suture; knoteless suture; total knee arthroplasty; wound; closure; time