Knee OsteoarthritisNCT03031314
Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
A study testing barbed suture and standard suture in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Washington Hospital Healthcare System.
Trial summary
Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries. The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- barbed suture and standard suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary joint replacement
Who cannot join
- no prior joint surgery
- no infection
About this study
Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.
The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.
Read more
Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).
Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- barbed suture, standard suture
- Keywords
- Joint Replacement, Knee Replacement, Wound Healing, Hip Replacement
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barbed sutureDevice
standard sutureDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard suture | Active comparator | standard suture used (monocryl) Receives: Device: standard suture |
| Barbed suture | Active comparator | barbed suture used (Quill suture, Surgical Specialties) Receives: Device: barbed suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of soft tissue infections
evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
Measured: 12 weeks
use of antibiotics to treat infection, recorded by number
record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded
Measured: 12 weeks
measurement of incision drainage, measured in grams and mm surface area
evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm
Measured: 2 weeks
assessment of quality of incision closure, recorded by time and number
record delayed healing and reported by time, suture rejection based on number of episodes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington Hospital Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Sah, MD, Washington Hospital Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031314
- Sponsor's protocol ID
- WHHSIJRR001
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients
- ClinicalTrials.gov ID
- NCT03031314
- Acronym / sponsor ID
- WHHSIJRR001
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Keywords
- Joint Replacement, Knee Replacement, Wound Healing, Hip Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Washington Hospital Healthcare SystemUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Barbed suture use has been gaining increased acceptance and has been reported to offer potential advantages in wound closure of hip and knee replacement surgeries.
The goal of this study is to compare joint replacement patient outcomes who receive a knotless barbed suture versus a traditional suture (randomized into two arms). The traditional suture used at our joint replacement program is defined as: interrupted sutures to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless barbed suture and the traditional sutures have similar suture size.
Patient outcomes examined will be patient range of motion (recorded daily) and complications with wound healing (evaluated periodically in-person at post-operative visits).
Secondary outcomes examined will include wound drainage on dressings by surface area and weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard suture | Active comparator | Device: standard suturestandard suture used (monocryl) |
| Barbed suture | Active comparator | Device: barbed suturebarbed suture used (Quill suture, Surgical Specialties) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary joint replacement
Key exclusion criteria (2 listed)
- no prior joint surgery
- no infection
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 |
|---|---|---|
| barbed suture | Device | Barbed suture |
| standard suture | Device | Standard suture |
Primary outcome
Number of soft tissue infections
Time frame: 12 weeks
evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
use of antibiotics to treat infection, recorded by number
Time frame: 12 weeks
record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded
measurement of incision drainage, measured in grams and mm surface area
Time frame: 2 weeks
evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm
assessment of quality of incision closure, recorded by time and number
Time frame: 12 weeks
record delayed healing and reported by time, suture rejection based on number of episodes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing barbed suture and standard suture in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Washington Hospital Healthcare System.
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 1 inclusion and 2 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of soft tissue infections (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 31 Jan 2017.