Trial Outcomes & Findings for Knotless Suture in Revision Total Joint Arthroplasty (NCT NCT04403919)
NCT ID: NCT04403919
Last Updated: 2024-04-17
Results Overview
Measurement of the time needed to properly close the wound with each technique.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
Up to a maximum of 66 minutes (perioperative)
Results posted on
2024-04-17
Participant Flow
Participant milestones
| Measure |
Revision Total Knee Arthroplasty: Control
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total Knee Arthroplasty: Active
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total Hip Arthroplasty: Control
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total Hip Arthroplasty: Active
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
30
|
18
|
11
|
|
Overall Study
COMPLETED
|
22
|
30
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Revision Total Knee Arthroplasty: Control
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total Knee Arthroplasty: Active
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total Hip Arthroplasty: Control
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total Hip Arthroplasty: Active
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Knotless Suture in Revision Total Joint Arthroplasty
Baseline characteristics by cohort
| Measure |
Revision Total Knee Arthroplasty: Control
n=22 Participants
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total Knee Arthroplasty: Active
n=30 Participants
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total Hip Arthroplasty: Control
n=18 Participants
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total Hip Arthroplasty: Active
n=10 Participants
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
n=5 Participants
|
63.3 years
n=7 Participants
|
61.7 years
n=5 Participants
|
64.9 years
n=4 Participants
|
63.4 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
30 participants
n=7 Participants
|
18 participants
n=5 Participants
|
10 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to a maximum of 66 minutes (perioperative)Measurement of the time needed to properly close the wound with each technique.
Outcome measures
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 Participants
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 Participants
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 Participants
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=10 Participants
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Time of Closure in Minutes
|
36.3 minutes
Interval 18.7 to 51.0
|
31.1 minutes
Interval 17.3 to 45.0
|
35.9 minutes
Interval 17.5 to 66.0
|
27.1 minutes
Interval 18.7 to 47.0
|
SECONDARY outcome
Timeframe: Day 90Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.
Outcome measures
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 Participants
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 Participants
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 Participants
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=10 Participants
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Incidence of Complications Related to Wound Closure
|
2 Total number of complications
|
4 Total number of complications
|
1 Total number of complications
|
0 Total number of complications
|
SECONDARY outcome
Timeframe: Week 6 Post-SurgeryThe POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically on a ten-step scale, where 0 = normal skin and 10 = worst scar imaginable. Together they make up the 'Total Score' of the Patient and Observer Scale, which ranges from 0 to 120; higher scores indicate worse scars.
Outcome measures
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 Participants
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 Participants
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 Participants
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=10 Participants
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Patient and Observer Scar Assessment Scale (POSAS) Score
|
2.7 score on a scale
Interval 1.0 to 4.0
|
3.4 score on a scale
Interval 1.0 to 5.0
|
2.5 score on a scale
Interval 1.0 to 5.0
|
2.6 score on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 45 minutes (perioperative)Outcome measures
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 Participants
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 Participants
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 Participants
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=10 Participants
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Mean Number of Sutures Used
|
10.9 sutures
Interval 4.0 to 15.0
|
6.3 sutures
Interval 4.0 to 10.0
|
9.1 sutures
Interval 5.0 to 12.0
|
5.9 sutures
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: 30 minutes (perioperative)Outcome measures
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 Participants
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 Participants
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 Participants
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=10 Participants
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Mean Length of Incision
|
196.4 millimeters
Interval 145.0 to 300.0
|
186 millimeters
Interval 110.0 to 290.0
|
168 millimeters
Interval 120.0 to 230.0
|
177 millimeters
Interval 135.0 to 240.0
|
Adverse Events
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Revision Total HIP Arthroplasty: Control (Conventional Closure)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 participants at risk
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 participants at risk
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 participants at risk
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=11 participants at risk
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Infections and infestations
Recurrent effusion
|
4.5%
1/22 • 3 months
|
0.00%
0/30 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/11 • 3 months
|
|
General disorders
Traumatic wound dehisence
|
0.00%
0/22 • 3 months
|
3.3%
1/30 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/11 • 3 months
|
|
Surgical and medical procedures
Lateral capsule weekness and herniation
|
0.00%
0/22 • 3 months
|
3.3%
1/30 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/11 • 3 months
|
Other adverse events
| Measure |
Revision Total KNEE Arthroplasty: Control (Conventional Closure)
n=22 participants at risk
Conventional Closure: Knee: Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson \& Johnson) and Dermabond advanced.
|
Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure)
n=30 participants at risk
Barbed suture closure: Knee: The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
|
Revision Total HIP Arthroplasty: Control (Conventional Closure)
n=18 participants at risk
Conventional Closure: Hip: 1. The capsule will be closed with Vicryl Plus number 1 2. Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus) 4. Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson) 5. followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
|
Revision Total HIP Arthroplasty: Active (Barbed Suture Closure)
n=11 participants at risk
Barbed suture closure: Hip: 1. The capsule will be closed with stratafix symmetric PDS Plus 2. Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ) 3. Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ) 4. Subcuticular suture with stratafix spiral monocryl plus, Ethicon 5. followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • 3 months
|
6.7%
2/30 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/11 • 3 months
|
|
General disorders
Delayed wound healing
|
0.00%
0/22 • 3 months
|
3.3%
1/30 • 3 months
|
0.00%
0/18 • 3 months
|
0.00%
0/11 • 3 months
|
|
General disorders
Instability/Dislocation
|
0.00%
0/22 • 3 months
|
0.00%
0/30 • 3 months
|
0.00%
0/18 • 3 months
|
9.1%
1/11 • 3 months
|
|
Infections and infestations
Recurrent effusion
|
4.5%
1/22 • 3 months
|
0.00%
0/30 • 3 months
|
5.6%
1/18 • 3 months
|
0.00%
0/11 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place