Analysis of Standard Versus Barbed Sutures in Primary Total Knee Arthroplasty.
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Purpose
Knotted suture have traditionally been used for surgical closures. The technique of closing a surgical incision with sutures tied with knots has been the standard for wound closure without any other alternative until recently. Knotted suture technique is a reliable and safe method for wound closure. However, knotted sutures do present several possible disadvantages. Knots take a long time to tie and may place difficult demands on tissue. The bulk of knots may cause tissue inflammation during the process of being absorbed and possibly an area for infection as well as a chance for scaring. Knotted sutures can push out through skin weeks after surgery allowing a site of incision infection. Also, repetitive needle handling during knot tying puts the surgeon at inherent risk.
Barbed sutures are self-anchoring and require no knots for wound closure. The lack of knots may provide several benefits. After surgery tissue strain may be decreased, potentially lowering the risk of reduced blood supply to local tissue. The absence of knots may lead to decreased skin irritation and superficial infections as the knots do not need to be absorbed. Additionally, speed of closure might be better with knot-less suture, allowing increased operative day efficiency and productivity. On the other hand, barbed sutures may have disadvantages. Suture pullout and breakage are both possible causes of suture failure with potentially more consequence due to lack of interrupted suture technique. In theory, if the barbed suture breaks near the midpoint, the angled barbs could allow pullout and wound breakdown. In a recent large review of total joint wound closures, barbed sutures were found to be safe. They have been used in a large number of patients for the past few years here at our center as well as many other centers without significant complications. Of note, all surgeons participating in this study have successfully used both of the above mentioned closure techniques for their patients in the recent past.
| Condition |
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Arthropathy of Knee |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Clinical Outcomes and Cost Analysis of Standard Versus Barbed Sutures for Closure in Primary Total Knee Arthroplasty: A Single Blinded Multicenter Prospective Randomized Trial. |
- To evaluate the clinical outcomes in terms of wound complications and patient satisfaction with barbed suture closure in total knee arthroplasty. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]There will be no significant difference in other wound complications or patient satisfaction in barbed suture closure as compared to standard closure technique in total knee arthroplasty.
- To evaluate the cost in terms of operative time and material costs of barbed suture closure in total knee arthroplasty. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]There will be significant shorter surgical wound closure times with the use of a barbed suture closure as compared to standard closure technique in total knee arthroplasty.There will be significant cost savings with the use of a barbed suture closure as compared to standard closure technique in total knee arthroplasty.
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Barbed sutures
barbed sutures are self-anchoring, requiring no knots for wound closure, which may have several advantages over knotted technique.
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knotted sutures
Knotted sutures used for traditional surgical closures.
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
The study and control groups will be made up of consecutive patients undergoing a median parapatellar approach primary total knee arthroplasty at the University of Utah Hospital and Clinics,The control group will undergo two-layer closure utilizing a standard interrupted, knotted suture technique. The closures will be performed by 2 members of the team (attending surgeon, resident, fellow, or PA) in ALL closures so as to limit the possible confounder of closure time variation due to different numbers of people closing the incision. This will specifically consist of arthrotomy closure using interrupted #1 Ethibond™ in figure of eight fashion and sudermal closure using 2-0 Monocryl™ in interrupted buried fashion.
Inclusion Criteria:
- Inclusion Criteria:
- Patients greater than 18 years of age diagnosed with arthritis of the knee that have elected to proceed with primary total knee arthroplasty respectively.
Exclusion Criteria:
- - Patients less than 18 years of age
- Prior open knee surgery in close proximity (<2cm) to the proposed incision for the primary total knee arthroplasty (prior arthroscopic surgery does not exclude a patient from the study)
- Wound or Scar in close proximity (<2cm) to the proposed incision for the primary total knee arthroplasty
Contacts and Locations| United States, North Carolina | |
| Duke University Health System | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Joint Implant Surgeons Inc, | |
| New Albany, Ohio, United States, 43054 | |
| United States, Texas | |
| Scott and White HealthCare | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| University of Utah Orthopedics Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Principal Investigator: | Christopher Peters, MD | University of Utah hopsital |
| Principal Investigator: | Jeremy Gililland, MD | University of Utah Orthopaedics Resident |
More Information
No publications provided
| Responsible Party: | University of Utah |
| ClinicalTrials.gov Identifier: | NCT01320371 History of Changes |
| Other Study ID Numbers: | 44725 |
| Study First Received: | March 18, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
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barbed sutures knotted sutures total knee arthroplasty knee surgery |
Additional relevant MeSH terms:
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Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013