ArthroplastyNCT04403919
Knotless Suture in Revision Total Joint Arthroplasty
A study testing Conventional Closure: Knee, Barbed suture closure: Knee and Conventional Closure: Hip in people with Arthroplasty, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- Conventional Closure: Knee, Barbed suture closure: Knee and Conventional Closure: Hip
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- 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
Who cannot join
- Patient is ≤ 18 years of age
- Patient is unable to provide written consent
- Patient has active infections in the operative leg/joint
- Known Allergy to Suture material
- 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
- Anterior total hip replacement
Show all 12Show fewer
- Stage 1 of two stage revision for infection
- Closure performed by plastic surgeon, including flap coverage
- Vulnerable populations will not be enrolled in this study.
- Withdrawal Criteria
- Failure to attend regularly scheduled follow up appointments
- Deviation from closure protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
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.
- Conditions
- Arthroplasty
- Being tested
- Conventional Closure: Knee, Barbed suture closure: Knee, Conventional Closure: Hip, Barbed suture closure: Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Closure: KneeDevice
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.
Barbed suture closure: KneeDevice
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.
Conventional Closure: HipDevice
- The capsule will be closed with Vicryl Plus number 1
- Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson \&Johnson, Somerville, NJ)
- Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus)
- Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson \& Johnson)
- followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson \&Johnson).
Barbed suture closure: HipDevice
- The capsule will be closed with stratafix symmetric PDS Plus
- Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson \&Johnson, Somerville, NJ)
- Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson \& Johnson, Somerville, NJ)
- Subcuticular suture with stratafix spiral monocryl plus, Ethicon
- followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson \&Johnson).
| Study group | Role | What they receive |
|---|---|---|
| Revision total knee arthroplasty: control | Active comparator | Not described Receives: Device: Conventional Closure: Knee |
| Revision total knee arthroplasty: active | Experimental | Not described Receives: Device: Barbed suture closure: Knee |
| Revision Total Hip Arthroplasty: control | Active comparator | Not described Receives: Device: Conventional Closure: Hip |
| Revision Total Hip Arthroplasty: active | Experimental | Not described Receives: Device: Barbed suture closure: Hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Closure in Minutes
Measurement of the time needed to properly close the wound with each technique.
Measured: Up to a maximum of 66 minutes (perioperative)
Secondary outcomes (4)
Incidence of Complications Related to Wound Closure
Number of all complications (including needle sticks and glove perforations) and infections related to the wound closure.
Measured: Day 90
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.
Measured: Week 6 Post-Surgery
Mean Number of Sutures Used
Measured: 45 minutes (perioperative)
Mean Length of Incision
Measured: 30 minutes (perioperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Sep 2020
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, controlled trial, parallel four-arm design, single-center study
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ran Schwarzkopf, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403919
- Sponsor's protocol ID
- 20-00280
- Status last verified
- Apr 2024
- First submitted
- 22 May 2020
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[contact information for PI or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knotless Suture in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04403919
- Acronym / sponsor ID
- 20-00280
- Conditions
- Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- prospective, randomized, controlled trial, parallel four-arm design, single-center study
| Arm | Type | Receives |
|---|---|---|
| Revision total knee arthroplasty: control | Active comparator | Device: Conventional Closure: Knee |
| Revision total knee arthroplasty: active | Experimental | Device: Barbed suture closure: Knee |
| Revision Total Hip Arthroplasty: control | Active comparator | Device: Conventional Closure: Hip |
| Revision Total Hip Arthroplasty: active | Experimental | Device: Barbed suture closure: Hip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age
- 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
Key exclusion criteria (12 listed)
- Patient is ≤ 18 years of age
- Patient is unable to provide written consent
- Patient has active infections in the operative leg/joint
- Known Allergy to Suture material
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Closure: KneeTraditional 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. | Device | Revision total knee arthroplasty: control |
| Barbed suture closure: KneeThe 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. | Device | Revision total knee arthroplasty: active |
| Conventional Closure: Hip1. 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). | Device | Revision Total Hip Arthroplasty: control |
| Barbed suture closure: Hip1. 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). | Device | Revision Total Hip Arthroplasty: active |
Primary outcome
Time of Closure in Minutes
Time frame: Up to a maximum of 66 minutes (perioperative)
Measurement of the time needed to properly close the wound with each technique.
4 secondary outcomes
Incidence of Complications Related to Wound Closure
Time frame: Day 90
Patient and Observer Scar Assessment Scale (POSAS) Score
Time frame: Week 6 Post-Surgery
Mean Number of Sutures Used
Time frame: 45 minutes (perioperative)
Mean Length of Incision
Time frame: 30 minutes (perioperative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ran Schwarzkopf, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Closure: Knee, Barbed suture closure: Knee and Conventional Closure: Hip in people with Arthroplasty, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Closure in Minutes (time frame: Up to a maximum of 66 minutes (perioperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.