Arthroplasty
Conditions
Brief summary
Barbed suture has been demonstrated to be safe in primary hip and knee surgery and retrospective data suggests barbed suture represents no increased complications in the revision setting. Barbed suture may represent a faster, more effective way to perform revision arthroplasty closures. There are no Level I studies comparing traditional and barbed suture closure. The purpose of this study is to assess the surgical complexities of closures using closure time without sacrificing cosmesis or wound complications between the traditional closure and barbed closure.
Interventions
DEVICEConventional 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.
DEVICEBarbed 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.
DEVICEConventional 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).
DEVICEBarbed 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).
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
prospective, randomized, controlled trial, parallel four-arm design, single-center study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients ≥ 18 years of age 2. Surgical candidates undergoing revision total knee or total hip arthroplasty for one of the following indications second stage of two stage reimplantation for infection, mechanical loosening, instability, polyethylene wear, stiffness, or periprosthetic fracture
Exclusion criteria
1. Patient is ≤ 18 years of age 2. Patient is unable to provide written consent 3. Patient has active infections in the operative leg/joint 4. Known Allergy to Suture material 5. Underlying Dermatological diseases affecting surgical site including dermatitis, eczema, or psoriasis; connective tissue or vascular disorders or diseases that would adversely affect wound healing; metastatic cancer; renal insufficiency (dialysis); steroid dependence; malnourishment; and other disease processes resulting in an immunocompromised state. Diabetes, smoking and obesity will be allowed as they are frequent comorbidities in our revision joint population 6. Anterior total hip replacement 7. Stage 1 of two stage revision for infection 8. Closure performed by plastic surgeon, including flap coverage Vulnerable populations will not be enrolled in this study. Withdrawal Criteria 1. Failure to attend regularly scheduled follow up appointments 2. Deviation from closure protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of Closure in Minutes | Up to a maximum of 66 minutes (perioperative) | Measurement of the time needed to properly close the wound with each technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complications Related to Wound Closure | Day 90 | Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure. |
| Patient and Observer Scar Assessment Scale (POSAS) Score | Week 6 Post-Surgery | The 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. |
| Mean Number of Sutures Used | 45 minutes (perioperative) | — |
| Mean Length of Incision | 30 minutes (perioperative) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 30 |
| 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). | 18 |
| 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). | 10 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Revision Total Knee Arthroplasty: Control | Total | Revision Total Hip Arthroplasty: Active | Revision Total Hip Arthroplasty: Control | Revision Total Knee Arthroplasty: Active |
|---|---|---|---|---|---|
| Age, Continuous | 64.3 years | 63.4 years | 64.9 years | 61.7 years | 63.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 18 Participants | 0 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 20 Participants | 2 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 41 Participants | 8 Participants | 10 Participants | 10 Participants |
| Region of Enrollment United States | 22 participants | 80 participants | 10 participants | 18 participants | 30 participants |
| Sex: Female, Male Female | 16 Participants | 53 Participants | 5 Participants | 14 Participants | 18 Participants |
| Sex: Female, Male Male | 6 Participants | 27 Participants | 5 Participants | 4 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 30 | 0 / 18 | 0 / 11 |
| other Total, other adverse events | 1 / 22 | 2 / 30 | 1 / 18 | 1 / 11 |
| serious Total, serious adverse events | 1 / 22 | 2 / 30 | 0 / 18 | 0 / 11 |
Outcome results
Primary
Time of Closure in Minutes
Measurement of the time needed to properly close the wound with each technique.
Time frame: Up to a maximum of 66 minutes (perioperative)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Revision Total KNEE Arthroplasty: Control (Conventional Closure) | Time of Closure in Minutes | 36.3 minutes |
| Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure) | Time of Closure in Minutes | 31.1 minutes |
| Revision Total HIP Arthroplasty: Control (Conventional Closure) | Time of Closure in Minutes | 35.9 minutes |
| Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Time of Closure in Minutes | 27.1 minutes |
Secondary
Incidence of Complications Related to Wound Closure
Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.
Time frame: Day 90
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Revision Total KNEE Arthroplasty: Control (Conventional Closure) | Incidence of Complications Related to Wound Closure | 2 Total number of complications |
| Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure) | Incidence of Complications Related to Wound Closure | 4 Total number of complications |
| Revision Total HIP Arthroplasty: Control (Conventional Closure) | Incidence of Complications Related to Wound Closure | 1 Total number of complications |
| Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Incidence of Complications Related to Wound Closure | 0 Total number of complications |
Secondary
Mean Length of Incision
Time frame: 30 minutes (perioperative)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Revision Total KNEE Arthroplasty: Control (Conventional Closure) | Mean Length of Incision | 196.4 millimeters |
| Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure) | Mean Length of Incision | 186 millimeters |
| Revision Total HIP Arthroplasty: Control (Conventional Closure) | Mean Length of Incision | 168 millimeters |
| Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Mean Length of Incision | 177 millimeters |
Secondary
Mean Number of Sutures Used
Time frame: 45 minutes (perioperative)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Revision Total KNEE Arthroplasty: Control (Conventional Closure) | Mean Number of Sutures Used | 10.9 sutures |
| Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure) | Mean Number of Sutures Used | 6.3 sutures |
| Revision Total HIP Arthroplasty: Control (Conventional Closure) | Mean Number of Sutures Used | 9.1 sutures |
| Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Mean Number of Sutures Used | 5.9 sutures |
Secondary
Patient and Observer Scar Assessment Scale (POSAS) Score
The 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.
Time frame: Week 6 Post-Surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Revision Total KNEE Arthroplasty: Control (Conventional Closure) | Patient and Observer Scar Assessment Scale (POSAS) Score | 2.7 score on a scale |
| Revision Total KNEE Arthroplasty: Active (Barbed Suture Closure) | Patient and Observer Scar Assessment Scale (POSAS) Score | 3.4 score on a scale |
| Revision Total HIP Arthroplasty: Control (Conventional Closure) | Patient and Observer Scar Assessment Scale (POSAS) Score | 2.5 score on a scale |
| Revision Total HIP Arthroplasty: Active (Barbed Suture Closure) | Patient and Observer Scar Assessment Scale (POSAS) Score | 2.6 score on a scale |