Clinical trial NCT04403919: Knotless Suture in Revision Total Joint Arthroplasty
Official title: Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled trial, parallel four-arm design, single-center study
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time of Closure in Minutes
timeFrame: Up to a maximum of 66 minutes (perioperative)
Secondary outcomes:
measure: Incidence of Complications Related to Wound Closure
timeFrame: Day 90
measure: Patient and Observer Scar Assessment Scale (POSAS) Score
timeFrame: Week 6 Post-Surgery
measure: Mean Number of Sutures Used
timeFrame: 45 minutes (perioperative)
measure: Mean Length of Incision
timeFrame: 30 minutes (perioperative)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ran Schwarzkopf, MD
role: PRINCIPAL_INVESTIGATOR
References: