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Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties

Primary Purpose

Knee Osteoarthritis, Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Knotless suture for wound closure
Layered traditional wound closure (monocryl)
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Safety, Efficacy, Cost-savings, Cosmesis, Safety and efficacy of wound closure, Cost-savings potential, Cosmesis of the wound/scar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients must be male or female of any race
  • Ages 18-80 years old
  • Patients must be undergoing a primary hip or knee arthroplasty
  • Patients must be able to understand and willing to cooperate with study procedures
  • Able to provide written and verbal informed consent

Exclusion Criteria:

  • Allergy or intolerance to the study materials
  • Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
  • History of previous surgeries on the affected joint other than arthroscopy (open surgeries)
  • History of any substance abuse or dependence within the last 6 months

Sites / Locations

  • Rush university Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Knotless suture for wound closure

Layered traditional wound closure (monocryl)

Outcomes

Primary Outcome Measures

Closure Time
We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.

Secondary Outcome Measures

Cost-analysis
Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs
Visual Analog Score, Cosmesis
Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis. 1 is an unacceptable or poor perspective in regards to wound cosmesis.

Full Information

First Posted
February 2, 2009
Last Updated
September 9, 2014
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00834483
Brief Title
Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties
Official Title
Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Barbed sutures offer several potential advantages in layered wound closure of hip and knee replacement surgeries. It use is gaining increased acceptance across many of the other surgical disciplines at this time. The purpose of this study is to evaluate the use of Quill as part of our layered closure compared to using our traditional sutures. The study timeline begins at the time of the surgical procedure and continues through the routine follow-up of total joint replacements at 2, 6, and 12 weeks, and will conclude at the six month post-operative office visit. Primary Objectives: To evaluate the safety and efficacy of wound closure in primary hip and knee replacements using a bidirectional barbed suture (knotless) compared to a traditional layered (vicryl) wound closure. Secondary Objectives: Establish the all around (intra-operative and post-operative) cost-savings potential in using a knotless wound closure compared to that of a layered vicryl closure (our standard suture protocol). Assess the overall cosmesis of the wound/scar as well as perceived presence of subcutaneous surgical knots, when using the knotless wound closure versus our traditional layered suture closure.
Detailed Description
We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated. Closure was noted to be significantly faster (9.3 vs 13.6 minutes, P b .005) in the barbed suture group. Wound-related complications were similar (3 cases) in both groups at 3-month follow-up. Although this study supports the use of barbed technology as a functionally comparable and more efficient modality of wound closure with the potential for costs savings based on reduced operative time, the cost-effectiveness of its adoption is institution dependent and will rely on the optimization of all other perioperative factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hip Osteoarthritis
Keywords
Safety, Efficacy, Cost-savings, Cosmesis, Safety and efficacy of wound closure, Cost-savings potential, Cosmesis of the wound/scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Knotless suture for wound closure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Layered traditional wound closure (monocryl)
Intervention Type
Device
Intervention Name(s)
Knotless suture for wound closure
Other Intervention Name(s)
Angiotech Quill SRS
Intervention Description
Angiotech Quill SRS
Intervention Type
Device
Intervention Name(s)
Layered traditional wound closure (monocryl)
Other Intervention Name(s)
Monocryl
Intervention Description
Layered traditional wound closure (monocryl)
Primary Outcome Measure Information:
Title
Closure Time
Description
We performed a prospective, randomized clinical trial to evaluate the efficacy of using a bidirectional barbed suture compared with traditional sutures in the deep closure of primary total hip (25) and knee (35) arthroplasties. Complications, time to closure, and length of surgery were evaluated.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cost-analysis
Description
Cost savings included the material costs and then we factored in the time savings in the OR. The OR time was based upon the average cost per minute to work in one of our ORs
Time Frame
1 year
Title
Visual Analog Score, Cosmesis
Description
Overall cosemesis was graded by patient and surgeon. This is based on a 1-6 scale, with a 6 being a perfect score based upon satisfaction with the wound cosmesis. 1 is an unacceptable or poor perspective in regards to wound cosmesis.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients must be male or female of any race Ages 18-80 years old Patients must be undergoing a primary hip or knee arthroplasty Patients must be able to understand and willing to cooperate with study procedures Able to provide written and verbal informed consent Exclusion Criteria: Allergy or intolerance to the study materials Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology History of previous surgeries on the affected joint other than arthroscopy (open surgeries) History of any substance abuse or dependence within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett R Levine, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush university Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18619922
Citation
Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
Results Reference
background
PubMed Identifier
17949320
Citation
Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007 Oct;21(10):1175-8. doi: 10.1089/end.2007.9913.
Results Reference
background
PubMed Identifier
18317092
Citation
Villa MT, White LE, Alam M, Yoo SS, Walton RL. Barbed sutures: a review of the literature. Plast Reconstr Surg. 2008 Mar;121(3):102e-108e. doi: 10.1097/01.prs.0000299452.24743.65.
Results Reference
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Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties

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