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

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00834483
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Hip Osteoarthritis	Device: Knotless suture for wound closure; Device: Layered traditional wound closure (monocryl)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties: A Prospective-randomized Clinical Trial
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Knotless suture for wound closure	Device: Knotless suture for wound closure; Angiotech Quill SRS; Other Names: Angiotech Quill SRS
Active Comparator: 2 Layered traditional wound closure (monocryl)	Device: Layered traditional wound closure (monocryl); Layered traditional wound closure (monocryl); Other Names: Monocryl

Outcome Measures

Primary Outcome Measures

1. Closure Time [6 months]

   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

1. Cost-analysis [1 year]

   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

2. Visual Analog Score, Cosmesis [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush university Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center

Investigators

• Principal Investigator: Brett R Levine, MD, Rush University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Review.

• Responsible Party: Brett Levine, MD, MD, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT00834483
• Other Study ID Numbers: 08091607
• First Posted: Feb 3, 2009
• Last Update Posted: Sep 11, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Brett Levine, MD, MD, Rush University Medical Center: Safety; Efficacy; Cost-savings; Cosmesis; Safety and efficacy of wound closure; Cost-savings potential; Cosmesis of the wound/scar
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Study Results

Participant Flow

Recruitment Details	This single-blinded, prospective, randomized trial was conducted from February 2009 through June 2009 and was approved by our institutional review board. Recruitment was in our office only.
Pre-assignment Detail	No participants were excluded except those that would not sign consent. 5 patients were excluded as they did not want to participate giving us 65 offers and 60 enrollments.

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	Knotless suture for wound closure	Layered traditional wound closure (monocryl)
Period Title: Overall Study
STARTED	31	29
COMPLETED	31	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment Group	Control Group	Total
Arm/Group Description	Knotless suture for wound closure	Layered traditional wound closure (monocryl)	Total of all reporting groups
Overall Participants	31	29	60
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 38.7%	10 34.5%	22 36.7%
>=65 years	19 61.3%	19 65.5%	38 63.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.4 (10.86)	63.5 (10.8)	63.95 (10.8)
Sex: Female, Male (Count of Participants)
Female	23 74.2%	21 72.4%	44 73.3%
Male	8 25.8%	8 27.6%	16 26.7%
Region of Enrollment (participants) [Number]
United States	31 100%	29 100%	60 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

A power analysis was performed based on mean closure times by the 2 surgeons and determined that a sample size of 23 patients in each group would provide 90% power to detect a 50% difference in closure time. To account for patients being lost to FU, we enrolled 29 to the traditional closure group and 31 to the barbed closure group

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	Knotless suture for wound closure	Layered traditional wound closure (monocryl)
Measure Participants	31	29
Mean (Full Range) [Average time in minutes]	9.34	13.57

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Power analysis was performed as above.

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	Knotless suture for wound closure	Layered traditional wound closure (monocryl)
Measure Participants	31	29
Mean (Standard Deviation) [Dollars]	52.75 (19.96)	12.79 (1.95)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Power analysis described above

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	Knotless suture for wound closure	Layered traditional wound closure (monocryl)
Measure Participants	31	29
Mean (Full Range) [units on a scale (1 is a low score)]	5.9	5.8

Adverse Events

Arm/Group Title	Treatment Group		Control Group
Arm/Group Description	Knotless suture for wound closure		Layered traditional wound closure (monocryl)
All Cause Mortality
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/31 (3.2%)		0/29 (0%)
Musculoskeletal and connective tissue disorders
Fall	1/31 (3.2%)	1	0/29 (0%)	0
Other (Not Including Serious) Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/31 (6.5%)		3/29 (10.3%)
Infections and infestations
incisional erythema	2/31 (6.5%)	2	3/29 (10.3%)	3

Limitations/Caveats

Five patients were offered enrollment but refused to participate, however this does not alter our data as sixty others did enroll.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.