Prospective Randomized Trial of Stratafix vs. Vicryl in Total Hip Arthroplasty.

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 hip 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).

Inclusion Criteria:

1. Males and females, between the ages of 18 to 80 years at the time of signing the
informed consent document.

2. Understand and voluntarily sign an informed consent document prior to any
study-related assessments/procedures are conducted.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Able to fluently speak and understand the local language

5. If female, is non-pregnant (negative pregnancy test results at the
baseline/randomization visit) and non-lactating.

6. End-stage osteoarthritis patients planning to undergo primary total hip arthroplasty

7. BMI less than 40 kg/m2

Exclusion Criteria:

1. BMI greater than or equal to 40 kg/m2.

2. History of known bleeding disorder.

3. History of medical co-morbidity that may result in poor wound healing (i.e. diabetes
mellitus, peripheral vascular disease).

4. Patients <18 or >80 years of age.

5. Patients who are prisoners.

6. Mentally unable to sign informed consent.

7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to
cause the patient to be withdrawn from the trial or would otherwise interfere with
interpreting the results of the study.