Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial

Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial

Accepted Manuscript Does barbed suture lower cost and improve outcome in total knee arthroplasty? A randomized controlled trial Vincent WK. Chan, MBBS...

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Accepted Manuscript Does barbed suture lower cost and improve outcome in total knee arthroplasty? A randomized controlled trial Vincent WK. Chan, MBBS, P.K. Chan, FHKCOS, FHKAM, Orthopaedic Surgery, K.Y. Chiu, FHKCOS, FHKAM, Orthopaedic Surgery, C.H. Yan, FHKCOS, FHKAM, Orthopaedic Surgery, F.Y. Ng, FHKCOS, FHKAM, Orthopaedic Surgery PII:

S0883-5403(16)30900-7

DOI:

10.1016/j.arth.2016.12.015

Reference:

YARTH 55546

To appear in:

The Journal of Arthroplasty

Received Date: 7 August 2016 Revised Date:

3 December 2016

Accepted Date: 12 December 2016

Please cite this article as: Chan VW, Chan P, Chiu K, Yan C, Ng F, Does barbed suture lower cost and improve outcome in total knee arthroplasty? A randomized controlled trial, The Journal of Arthroplasty (2017), doi: 10.1016/j.arth.2016.12.015. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Does barbed suture lower cost and improve outcome in total knee arthroplasty? A randomized controlled trial.

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1. Division of Joint Replacement Surgery Department of Orthopaedics and Traumatology The University of Hong Kong Queen Mary Hospital 102 Pokfulam Road Hong Kong, SAR, China

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Vincent WK. Chan, MBBS1 PK. Chan, FHKCOS, FHKAM (Orthopaedic Surgery) 1 KY. Chiu, FHKCOS, FHKAM (Orthopaedic Surgery) 1 CH. Yan, FHKCOS, FHKAM (Orthopaedic Surgery) 1 FY. Ng, FHKCOS, FHKAM (Orthopaedic Surgery) 1

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Please address all correspondence to: Vincent WK. Chan, MBBS Department of Orthopaedics and Traumatology The University of Hong Kong Queen Mary Hospital 102 Pokfulam Road Hong Kong, SAR, China

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Phone: +(852) 22554654 Fax: +(852) 28174392 E-mail: [email protected]

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Title

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Does barbed suture lower cost and improve outcome in total knee arthroplasty? A randomized

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controlled trial.

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Abstract

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Background

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Wound closure is key to prevent infection, facilitate immediate rehabilitation and improve efficiency of

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total knee arthroplasty (TKA). Continuous knotless suturing with barbed suture can potentially save time

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and distribute tension more evenly. However, its role in TKA in terms of cost-effectiveness and wound

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complications is not clear. This study aims to compare barbed and traditional sutures wound closure

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time and cost in primary total knee arthroplasty.

11 Methods

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One hundred and nine knees were randomized into either barbed or traditional group. Synthetic

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absorbable sutures (Vicryl, Ethicon Inc, United States) and bidirectional barbed sutures (Stratafix,

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Ethicon Inc, United States) were used. Arthrotomy and subcutaneous wound closure time, wound

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complications, and rehabilitation parameters in terms of range of motion (ROM) and Knee Society Score

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(KSS) were compared. Patients were followed up to 3 months.

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Results

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Traditional sutures had significantly more positive leak tests (10 versus 2, p-value <0.05) and wound

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complications (11 versus 2, p-value <0.05). No differences in ROM and KSS were noted. Arthrotomy and

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subcutaneous closure time was significantly shorter with barbed sutures (arthrotomy 325 seconds

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versus 491 seconds; subcutaneous 306 seconds versus 381 seconds, p-value <0.05). Concerning cost of

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suture material and operation time, barbed suture on average saved USD 48.7 per TKA in our local

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institute.

26 Conclusion

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Bidirectional barbed suture improves the cost-effectiveness of TKA through reducing wound closure

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time and wound complications.

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30 Introduction:

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Demand for total knee arthroplasty (TKA) is increasing all across the world and is estimated to increase

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by 600% in next 20 years [1,2,3]. It will be difficult to cope with just allocating more resources into joint

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replacement surgeries. Therefore, improving cost-effectiveness will be beneficial. Efficiency of TKA can

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be improved in various aspects, such as minimizing complications, improving surgical techniques, fast-

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track rehabilitation, blood product management and pain control. Preventing complications, especially

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infection, will be the most important as treating an infected TKA will cost at least 4 times the resources

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of a primary TKA [4]. Wound closure plays a key role in both preventing infections and improving

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efficiency of TKA. Quality wound closure is even more important in the era of fast-track arthroplasty

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with more aggressive rehabilitation and earlier discharge from hospital. The surgical wound in TKA is

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closed in layers, which takes up a significant portion of operative time. Traditionally, the arthrotomy is

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closed by interrupted sutures with multiple knots, which is time consuming and creates uneven tension.

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Bidirectional barbed suture was first introduced in 2007. It allows simultaneous bidirectional knotless

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suturing, which can potentially save time and distribute tension evenly [5,6,7,8]. Biomechanical studies

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in cadavers showed that it can withstand high tensile strength, provide more watertight closure and

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more resistant to cyclical loading than traditional sutures [9,10,11]. Despite all potential advantages,

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barbed suture is not commonly used in TKA. This might due to its higher cost and uncertain clinical

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2|P age

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benefits. Previous research on barbed sutures in TKA is limited and has yielded conflicting results. Some

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studies showed that barbed sutures have more wound complications [12,13], while others found that

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they reduce closure time and cost [5,6,7].

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The primary aim of this study is to compare the efficiency of barbed and traditional sutures in wound

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closure time and cost. A secondary aim is to compare wound complications and clinical outcome after

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TKA, in terms of Knee Society Score (KSS) and range of movement (ROM). We hypothesize that barbed

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suture can improve the efficiency of TKA with no differences in wound complications and clinical

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outcomes.

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57 Patients and Methods:

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This is a single-centre, randomized controlled trial (RCT) approved by our Institutional Review Board.

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Patients with osteoarthritis requiring primary TKA in our institute were recruited. Exclusion criterion

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includes revision arthroplasty, prior surgical incision or underlying dermatological disease affecting the

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surgical site, and those who refused to consent. Patients were randomized to either barbed or

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traditional group in a 1:1 ratio using statistical software. Bilateral TKAs were performed in an one-staged

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sequential manner and each knee was randomized independently.

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All TKAs were conducted by the same surgical team with standardized surgical technique and

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rehabilitation protocol.

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3|P age

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For the traditional group, interrupted size 1 and continuous size 2/0 synthetic absorbable sutures (Vicryl,

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Ethicon Inc, United States) were used for arthrotomy and subcutaneous closure respectively. Two

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surgeons were involved in arthrotomy closure, while one for subcutaneous closure. For the barbed

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group, knotless suturing of size 1 and 0 bidirectional barbed sutures (Stratafix, Ethicon Inc, United States)

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were used for arthrotomy and subcutaneous closure respectively with five back-throw at the ends of the

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wound. Two surgeons were involved in both arthrotomy and subcutaneous closure. In both groups,

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knee was flexed at 90 degrees during wound closure and skin was closed with surgical staples (Appose,

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Medtronics, United States). Arthrotomy and subcutaneous closure times were recorded by a theatre

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nurse with an electronic timer. Wound closure time starts when the first suture was placed and stops

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when the last suture end is cut.

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Intra-articular tranexamic acid (1g in 10ml of normal saline) is given routinely in our institute for

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haemostasis. A leak test was performed after arthrotomy closure and intra-articular tranexamic acid

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injections. Leakage of blood or fluid on full knee flexion is considered positive. Incision length was

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measured in full knee extension. Number of suture used and other intra-operative events (needle stick

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injury, glove perforation and suture breakage) were documented.

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Patients were followed up at 2 weeks, 6 weeks and 3 months in speciality out-patient clinic. Wound

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complications, KSS and ROM was charted. Wound complications were diagnosed by the attending

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surgeon based on the Centers for Disease Control and Prevention criterions [14]. The patients and their

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attending nurses or surgeons in the clinic were all blinded as to which arm of the study they were in.

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Assessment in the clinic were performed by clinic nurses and surgeon of our surgical team, who were

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not present during the surgery, to ensure blinding is not breeched. 4|P age

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92 Student T-test, Fisher-exact test, and Mann-Whitney U-test were used to compare parametric, non-

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parametric and ordinal data respectively. Power analysis (alpha 0.5, power 0.8) based on our pilot

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samples (data not shown) revealed that 25 TKAs in each group were needed to detect 2 minutes

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difference in wound closure time. GraphPad software (San Diego, CA USA) was used for statistical

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analysis. P-value <0.05 is considered statistically significant.

Results:

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Ninty nine patients (123 TKAs) were invited to participate in this study. Six patients (6 TKAs) refused to

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consent. Four knees in each group were excluded, because study protocols were not followed. Fifty five

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TKAs in the barbed group and 54 in the traditional group were included for final analysis. No patient

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withdrew or was lost to follow-up (Figure 1). Baseline demographics, co-morbidities, underlying

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aetiology, pre-operative clinical parameters and deformity were comparable between the two groups

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(Table 1).

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There were significantly more positive leak tests in traditional group (Table 2). No differences were seen

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in the number of needle stick injuries, suture breakages, or glove perforations between the two groups

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(data not shown). Both arthrotomy and subcutaneous closure time were significantly shorter in barbed

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group (Table 2). Total wound closure time was 241 seconds faster with continuous knotless suturing. No

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significant differences were noted in incision length between the two groups (Table 2).

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Regarding wound complications, there was 1 stitch abscess and 1 superficial dehiscence in the barbed

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group, while there were 5 stitch abscesses, 1 superficial cellulitis and 3 superficial dehiscences in the

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traditional group. All wound complications were minor and resolved with dressing changes with or

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without antibiotics (Table 2). No significant differences were noted between the two groups when

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individual complications were compared. However, the total number of wound complications were

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significantly higher in the traditional group (Table 2). No significant differences were found in ROM and

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KSS (Table 2).

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Suture material cost is calculated by multiplying the cost of each suture and the number of suture used

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per TKA. Barbed suture material cost USD 47.4 more per TKA than traditional sutures (Table 3). However,

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barbed suture reduces cost through saving time. The cost of operation per unit time (after excluding the

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cost of implants and other consumables) in our institute is USD 0.399 per second. Hence, barbed suture

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reduced cost by USD 96.2 per TKA. Considering both suture material and operation cost, barbed suture

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on average saved USD 48.8 for each TKA in our institute (Table 4). With reference to the operation cost

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in the United States, we estimate USD 203.2 saved per TKA in the United states with the use of barbed

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sutures (Table 4).

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Discussion:

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Demand for TKA is ever increasing. With our aging population and limited medical resources, it will be

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difficult to cope without improving cost-effectiveness of TKA. Our study demonstrated that bidirectional

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barbed suture reduced both wound closure time and operative cost without compromise in patient’s

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safety and clinical outcome.

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135 In this study, interrupted traditional sutures were compared with continuous barbed sutures. We

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believe this is a valid comparison because barbed suture behaves as interrupted sutures mechanically. It

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will not fail easily with breakage or loosening of individual suture loops due to even distribution of barbs

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throughout the suture. This security is important to ensure watertight closure in arthrothomy wounds.

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Perhaps other researchers also shared similar belief and made comparisons between running barbed

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and interrupted traditional sutures [5,6,7,12,13].

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More knees than required from power analysis were included in this study. The original power analysis

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was based on detecting differences in wound closure time. During the course of the study, we found a

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trend of more wound complications and arthrotomy leakages with traditional sutures, therefore, we

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included more knees to see if this trend is significant. With our current sample size, barbed suture had

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significantly less wound complications, especially stitch abscess and wound dehiscence. Traditional

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suture requires multiple knots, which increases foreign body reaction and act as nidus of infection,

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increasing the chance of stitch abscess formation and wound infection [16,17,18]. Moreover, uneven

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wound tension with interrupted suture increases tissue ischemia and increases the risk of wound

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dehiscence [6,16,19]. Although all wound complications in this study were minor and resolved with

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conservative care. Wound complications if not managed appropriately will progress to superficial and

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even deep infections. Therefore, any wound problems will increase nursing care, out-patient clinic

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consultations and psychological burden to patients. One of the limitations of this study is that the extra

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resources in managing wound complications were not accounted in the cost-analysis.

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7|P age

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Previous biomechanical studies in cadaver showed that barbed suture provides a more watertight

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arthrotomy closure and more robust to cyclical loading [11,20]. This supports our findings that barbed

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suture had significantly less arthrotomy leakage than traditional suture. To our knowledge, this is the

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first in vivo demonstration of barbed suture’s biomechanical advantage. Arthrotomy leakage in TKA

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would potentially reduce efficacy of intra-articular tranexamic acid, increase subcutaneous hematoma

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and wound complications. Recently, a meta-analysis by Zhang et al, included 4 RCTs and 3 retrospective

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reviews, reported significantly less major complications and superficial infections if arthrotomy wound is

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closed by barbed sutures [21]. Their findings further echo the result of this study, and perhaps such

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differences can be explained by less arthrotomy leakage with barbed suturing.

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Zhang et al also found that barbed suture can reduce wound closure time by 3.56 minutes and lower

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cost by 290.72 USD than traditional sutures [21]. The time saved is comparable to this study, however

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the cost saved is variable depending on the cost of operation in each locality. Besides lowering cost,

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shorter operation time can reduce time of wound exposure and allow more efficient use of medical and

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nursing staffs. These potential benefits were not considered in the cost-analysis.

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This is a patient and assessor blinded, randomized controlled trial which provides high level of evidence.

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Compliance rate of this study was high, with no drop out or lost to follow-up. All TKAs and follow-ups

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were performed by the same surgical team with standardized rehabilitation protocol. In conclusion,

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bidirectional barbed suture was more efficient than traditional suture in TKA in terms of both operation

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time and cost. Moreover, barbed suture was associated with less arthrotomy leakage and less wound

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complications.

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References

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1. Swedish Knee Arthroplasty Register Annual Report 2014.

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http://www.myknee.se/pdf/SKAR2014_Eng_1.1.pdf (last accessed 13 March 2016)

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2. National Joint Registry 12th Annual Report.

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http://www.njrcentre.org.uk/njrcentre/Portals/0/Documents/England/Reports/12th%20annual%20rep

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ort/NJR%20Online%20Annual%20Report%202015.pdf (last accessed 13 March 2016)

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3. Kurtz et al. Future young patient demand for primary and revision joint replacement: national

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projection from 2010-2030. Clin Orthop Relat Res 2009;467(10):2602-12

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4. Jaekel et al. Epidemiology of Total Hip and Knee Arthroplasty Infection. PJI of hip and knee 2014:1-14

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5. Sah PA. Is there an advantage to knotless barbed suture in TKA wound closure? A randomized trial in

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simultaneous bilateral TKAs. Clin Orthop Relat Res 2015;473(6):2019-2027.

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6. Gililland JM, Anderson LA et al. Barbed versus standard sutures for closure in total knee arthroplasty:

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A multicenter prospective randomized trial. J Arthroplasty 2014;29:135-138

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7. Ting TN, Moric MM et al. Use of knotless suture for closure of total hip and knee arthroplasties. J

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Arthoplasty 2012;27:1783-1788

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8. Paul M. Bidirectional barbed sutures for wound closure: evolution and applications. J AM Col Certif

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Wound Spec 2009;1:51-57

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9. Oni G et al. A comparison between barbed and non-barbed absorbable suture for fascial closure in a

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porcine model. Plast Reconstr Surg 2012;130(4): 535e-540e

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10. Zaruby J et al. An in vivo comparison of barbed sutures devises and conventional monofilament

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sutures for cosmetic skin closure: biomechanical wound strength and histology. Aesthet Surg J

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2011;31(2):232

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9|P age

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11. Nett M, Avelar R et al. Water-tight knee arthrotomy closure: comparison of a novel single

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bidirectional barbed self-retaining running suture versus conventional interrupted sutures. J Knee Surg

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2011;24:55-60

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12. Smith EL, DiSegna ST et al. Barbed versus traditional sutures: closure time, cost and wound related

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outcomes in total joint arthoplasty. J of Arthoplasty 2014;29:283-287

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13. Campbell AL, Partick DA Jr et al. Superficial wound closure complications with barbed sutures

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following knee arthoplasty. J Arthoplasty 2014;29:966-9

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14. Mangram A et al. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control

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Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20(4):250-78

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15. Macario A. What does one minute of operating room time cost? J Clin Anesth 2010;22(4):233-6

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16. Murtha AP, Kaplan AL, Paglia MJ et al. Evaluation of a novel technique for wound closure using

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barbed suture. Plast Reconstr Surg 2006;117(6):1769

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17. Price PB. Stress, strain and sutures. Ann Surg 1948;128(3):408-21

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18. Hogstrom H, Haglund U and Zederfeldt B. Tension leads to increased neutrophil accumulation and

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decreased laparotomy wound strength. Surgery 1990;107(2):215-9

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19. Jonsson T and Hogstrom H. Effect of suture technique on early healing of intestinal anastomoses in

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rats. Eur J Surg 1992;158(5):267-70

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20. Vakil et al. Knee arthrotomy repair with a continuous barbed suture: a biomechanical study. J

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Arthroplasty 2011; 26(5) 710-3

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21. Zhang W, Xue D, Yin H et al. Barbed versus traditional sutures for wound closure in knee

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arthroplasty: a systemic review and meta-analysis. Scientific Report 2016;6:19764

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Acknowledgement Funding:

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This work was supported by Queen Mary Hospital Charitable Trust – Training and Research Assistance Scheme (Reference no. TRAS-14-08 (02/14/179))

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Table 1 Baseline demographics, underlying aetiology, co-morbidities and pre-operative clinical parameters for barbed and traditional group (Data shown in mean ± standard deviation)

Demographics Age (years)

70.5 ± 8.2

Gender (Male: Female)

9 : 46 26.8 ± 1.2

Laterality (L : R) Underlying aetiology Primary osteoarthritis (%)

Co-morbidities Diabetes mellitus (%) Smoker (%)

70.4 ± 8.9

0.96

7: 47

0.78

26.5 ± 3.9

0.31

32 : 23

24 : 30

0.18

92.7%

94.4%

1.0

7.3%

5.6%

1.0

29.1%

18.5%

0.26

10.9%

9.3%

1.0

40.8 ± 16

44.3 ± 16

0.24

96 ± 13

98 ± 16

0.55

53 : 2

51 : 3

0.67

11.0 ± 7.2

10.8 ± 6.0

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Rheumatoid arthritis (%)

(n=54)

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Body Mass Index (kg/m2)

p-value

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(n=55)

Traditional group

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Barbed group

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Pre-operative clinical parameters

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Knee Society Score

Knee range of movement (degrees)

Pre-operative deformity Varus : valgus

Mechanical tibiofemoral angle

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Table 2 Wound closure time, intra-operative events and post-operative outcomes for barbed and traditional group (Data shown in mean ± standard deviation; * denotes p-value <0.05)

Intra-operative events Incision length (cm)

14.4 ± 1.2

Leak test

2

p-value

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(n=55)

Traditional group (n=54)

14.5 ± 1.7

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Barbed group

0.79

10

* 0.02

325 ± 75

491 ± 131

* < 0.001

306 ± 75

381 ± 113

* < 0.001

1

5

0.11

0

1

1.0

0

0

1.0

1

3

0.36

2

9

* 0.03

6 weeks

101 ± 14.5

103 ± 12.1

0.43

3 months

103 ± 12.6

107 ± 10.9

0.13

6 weeks

85 ± 8.4

86 ± 9.4

0.64

3 months

87 ± 7.3

90 ± 7.4

0.07

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Wound closure time Arthrotomy (second) Subcutaneous (second) Wound complications

Superficial infection Deep infection Dehiscence

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Stitch abscess

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Total wound complications

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Knee range of movements (degrees)

Knee Society Score

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Table 3 Suture material cost calculation for barbed and traditional suture

Suture used per

Suture cost per

Total suture cost

(USD)

TKA

TKA

per TKA

(USD)

29.8

1.07

Size 0

29.4

1.02

Traditional group 3.1

2/0

5.6

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61.9

30.0

2.5

7.8

1.2

6.7

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1/0

31.9

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Barbed group

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Cost per suture

14.5

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Table 4 Cost-analysis for barbed suture (considering operation time and suture material cost) Operation cost

Operation

Extra suture

Net cost saved

saved

per second

cost saved

cost (USD)

per TKA

(seconds)

(USD/seconds)

(USD)

Our institution

241

0.399

96.2

Hospital in United

241

1.04

250.6

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(USD)

47.4

48.8

47.4

203.2

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states (12,15)

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Operation time

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Figure 1 Flow diagram of the study

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