Knotless Suture in Revision Total Joint Arthroplasty

Arthroplasty Clinical Trial

Official title:

Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403919
• Other study ID #: 20-00280
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients = 18 years of age

2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture

Exclusion Criteria:

1. Patient is = 18 years of age

2. Patient is unable to provide written consent

3. Patient has active infections in the operative leg/joint

4. Known Allergy to Suture material

5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population

6. Anterior total hip replacement

7. Stage 1 of two stage revision for infection

8. Closure performed by plastic surgeon, including flap coverage

Vulnerable populations will not be enrolled in this study.

Withdrawal Criteria

1. Failure to attend regularly scheduled follow up appointments

2. Deviation from closure protocol

Related Conditions & MeSH terms

• Arthroplasty

Intervention

Device:
• Conventional Closure: Knee
Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced.
• Barbed suture closure: Knee
The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
• Conventional Closure: Hip
The capsule will be closed with Vicryl Plus number 1 Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ) Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson) followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson).
• Barbed suture closure: Hip
The capsule will be closed with stratafix symmetric PDS Plus Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ) Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ) Subcuticular suture with stratafix spiral monocryl plus, Ethicon followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson).

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of Closure in Minutes	Measurement of the time needed to properly close the wound with each technique.	Up to a maximum of 66 minutes (perioperative)
Secondary	Incidence of Complications Related to Wound Closure	Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.	Day 90
Secondary	Patient and Observer Scar Assessment Scale (POSAS) Score	The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.	Week 6 Post-Surgery
Secondary	Mean Number of Sutures Used		45 minutes (perioperative)
Secondary	Mean Length of Incision		30 minutes (perioperative)