Trial Outcomes & Findings for Use of Knotless Suture for Closure of Total Hip and Knee Arthroplasties (NCT NCT00834483)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

65 participants

Primary outcome timeframe

6 months

Results posted on

2014-09-11

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Treatment Group Knotless suture for wound closure	Control Group Layered traditional wound closure (monocryl)
Overall Study STARTED	31	29
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=31 Participants Knotless suture for wound closure	Control Group n=29 Participants Layered traditional wound closure (monocryl)	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Continuous	64.4 years STANDARD_DEVIATION 10.86 • n=5 Participants	63.5 years STANDARD_DEVIATION 10.8 • n=7 Participants	63.95 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=31 Participants Knotless suture for wound closure	Control Group n=29 Participants Layered traditional wound closure (monocryl)
Closure Time	9.34 Average time in minutes Interval 5.4 to 13.8	13.57 Average time in minutes Interval 7.0 to 26.2

SECONDARY outcome

Timeframe: 1 year

Population: Power analysis was performed as above.

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

Outcome measures

Outcome measures
Measure	Treatment Group n=31 Participants Knotless suture for wound closure	Control Group n=29 Participants Layered traditional wound closure (monocryl)
Cost-analysis	52.75 Dollars Standard Deviation 19.96	12.79 Dollars Standard Deviation 1.95

SECONDARY outcome

Timeframe: 6 months

Population: Power analysis described above

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=31 Participants Knotless suture for wound closure	Control Group n=29 Participants Layered traditional wound closure (monocryl)
Visual Analog Score, Cosmesis	5.9 units on a scale (1 is a low score) Interval 1.0 to 6.0	5.8 units on a scale (1 is a low score) Interval 1.0 to 6.0

Adverse Events

Treatment Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group n=31 participants at risk Knotless suture for wound closure	Control Group n=29 participants at risk Layered traditional wound closure (monocryl)
Musculoskeletal and connective tissue disorders Fall	3.2% 1/31 • Number of events 1	0.00% 0/29

Other adverse events

Other adverse events
Measure	Treatment Group n=31 participants at risk Knotless suture for wound closure	Control Group n=29 participants at risk Layered traditional wound closure (monocryl)
Infections and infestations incisional erythema	6.5% 2/31 • Number of events 2	10.3% 3/29 • Number of events 3

Additional Information

Dr. Brett R. Levine

Rush University Medical Center

Phone: 312-432-2466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place