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Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients

NCT ID: NCT03031314

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-01-01

Brief Summary

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Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.

The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.

Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).

Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.

Detailed Description

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Conditions

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Knee Osteoarthritis Hip Osteoarthritis

Keywords

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Joint Replacement Knee Replacement Wound Healing Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Standard suture

standard suture used (monocryl)

Group Type ACTIVE_COMPARATOR

standard suture

Intervention Type DEVICE

Barbed suture

barbed suture used (Quill suture, Surgical Specialties)

Group Type ACTIVE_COMPARATOR

barbed suture

Intervention Type DEVICE

Interventions

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barbed suture

Intervention Type DEVICE

standard suture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* primary joint replacement

Exclusion Criteria

* no prior joint surgery
* no infection
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington Hospital Healthcare System

OTHER

Sponsor Role lead

Responsible Party

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Alexander Sah, MD

Physician and Research Chair, Institute for Joint Restoration and Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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WHHSIJRR001

Identifier Type: -

Identifier Source: org_study_id