Hip Osteoarthritis, Knee Osteoarthritis
Conditions
Keywords
Safety, Efficacy, Cost-savings, Cosmesis, Safety and efficacy of wound closure, Cost-savings potential, Cosmesis of the wound/scar
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.
Interventions
DEVICEKnotless suture for wound closure
Angiotech Quill SRS
DEVICELayered traditional wound closure (monocryl)
Layered traditional wound closure (monocryl)
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Knotless suture for wound closure | 31 |
| Control Group Layered traditional wound closure (monocryl) | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 19 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 10.8 | 64.4 years STANDARD_DEVIATION 10.86 | 63.95 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 31 | 3 / 29 |
| serious Total, serious adverse events | 1 / 31 | 0 / 29 |
Outcome results
Primary
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | Closure Time | 9.34 Average time in minutes |
| Control Group | Closure Time | 13.57 Average time in minutes |
Secondary
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
Time frame: 1 year
Population: Power analysis was performed as above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Cost-analysis | 52.75 Dollars | Standard Deviation 19.96 |
| Control Group | Cost-analysis | 12.79 Dollars | Standard Deviation 1.95 |
Secondary
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.
Time frame: 6 months
Population: Power analysis described above
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group | Visual Analog Score, Cosmesis | 5.9 units on a scale (1 is a low score) |
| Control Group | Visual Analog Score, Cosmesis | 5.8 units on a scale (1 is a low score) |