Knee ArthroscopyNCT05822973
Sutures for Treatment of Knee Arthroscopy
A study testing 3.0 monocryl suture and 3.0 nylon suture in people with Knee Arthroscopy and Suture, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroscopy, Suture
- What is being tested?
- 3.0 monocryl suture and 3.0 nylon suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2018to 9 Apr 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ages 18 and older undergoing primary knee arthroscopy for diagnostic arthroscopy, removal of a loose body, chondroplasty, or a partial meniscectomy will be included in this analysis
Who cannot join
- Patients undergoing revision knee arthroscopy as well as patients undergoing ACL reconstruction or meniscal repair surgery will be excluded from this analysis.
- Patients under the age of 18 will be excluded as well.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Absorbable Versus Nonabsorbable Sutures for the Treatment of Knee Arthroscopy: A Prospective Comparison of Patient Outcomes and Satisfaction
For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Some surgeons prefer using nonabsorbable sutures due to it being easier to tie, these sutures are less likely to break prematurely, and that they elicit a minimal inflammatory response. On the other hand, some surgeons prefer using absorbable sutures due to the time savings of not having to remove the sutures at a later date and that these sutures decrease patient anxiety and discomfort. The purpose of this study is to prospectively investigate and compare patient's pain, swelling and cosmesis following knee arthroscopy surgery between patients who had their arthroscopy portals closed using resorbable sutures vs. patients who had their portals closed using nonabsorbable sutures.
- Conditions
- Knee Arthroscopy, Suture
- Being tested
- 3.0 monocryl suture, 3.0 nylon suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.0 monocryl sutureDevice
incision will be closed with absorbable suture
3.0 nylon sutureDevice
incision will be closed with non-absorbable suture
| Study group | Role | What they receive |
|---|---|---|
| would closure using absorbable sutures | Active comparator | patients randomized into the absorbable suture group will have their incisions closed with 3.0 monocryl sutures Receives: Device: 3.0 monocryl suture |
| would closure using non-absorbable sutures | Active comparator | Patients randomized into the nonabsorbable suture group will have their incisions closed with either a 3.0 nylon suture Receives: Device: 3.0 nylon suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Leveles
Pain levels will be recorded through the Visual Analogue Scale (VAS)
Measured: 3 months
Patient Satisfaction
Satisfaction will be measures with customized questions regarding the overall satisfaction of their incision (on a scale of 0 to 10), satisfaction of the suture removal process, complications and swelling
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start18 Nov 2018
- Primary completion9 Apr 2023
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822973
- Sponsor's protocol ID
- KFRE18D.721
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Versus Nonabsorbable Sutures for the Treatment of Knee Arthroscopy: A Prospective Comparison of Patient Outcomes and Satisfaction
- ClinicalTrials.gov ID
- NCT05822973
- Acronym / sponsor ID
- KFRE18D.721
- Conditions
- Knee Arthroscopy, Suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 18 Nov 2018 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- 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.
For a knee arthroscopy, two small incisions are made at the level of the joint line on each side of the patellar tendon. Closure of surgical incisions consists of using either nonabsorbable or absorbable sutures. Some surgeons prefer using nonabsorbable sutures due to it being easier to tie, these sutures are less likely to break prematurely, and that they elicit a minimal inflammatory response. On the other hand, some surgeons prefer using absorbable sutures due to the time savings of not having to remove the sutures at a later date and that these sutures decrease patient anxiety and discomfort. The purpose of this study is to prospectively investigate and compare patient's pain, swelling and cosmesis following knee arthroscopy surgery between patients who had their arthroscopy portals closed using resorbable sutures vs. patients who had their portals closed using nonabsorbable sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| would closure using absorbable sutures | Active comparator | Device: 3.0 monocryl suturepatients randomized into the absorbable suture group will have their incisions closed with 3.0 monocryl sutures |
| would closure using non-absorbable sutures | Active comparator | Device: 3.0 nylon suturePatients randomized into the nonabsorbable suture group will have their incisions closed with either a 3.0 nylon suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ages 18 and older undergoing primary knee arthroscopy for diagnostic arthroscopy, removal of a loose body, chondroplasty, or a partial meniscectomy will be included in this analysis
Key exclusion criteria (2 listed)
- Patients undergoing revision knee arthroscopy as well as patients undergoing ACL reconstruction or meniscal repair surgery will be excluded from this analysis.
- Patients under the age of 18 will be excluded as well.
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 |
|---|---|---|
| 3.0 monocryl sutureincision will be closed with absorbable suture | Device | would closure using absorbable sutures |
| 3.0 nylon sutureincision will be closed with non-absorbable suture | Device | would closure using non-absorbable sutures |
Primary outcome
Postoperative Pain Leveles
Time frame: 3 months
Pain levels will be recorded through the Visual Analogue Scale (VAS)
Patient Satisfaction
Time frame: 3 months
Satisfaction will be measures with customized questions regarding the overall satisfaction of their incision (on a scale of 0 to 10), satisfaction of the suture removal process, complications and swelling
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 21 Apr 2023.
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Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
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Geko™ Device in Prevention of Pain and Swelling Following Knee Arthroscopy
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Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3.0 monocryl suture and 3.0 nylon suture in people with Knee Arthroscopy and Suture, run by Rothman Institute Orthopaedics 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 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 21 Apr 2023. 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?
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?
Postoperative Pain Leveles (time frame: 3 months). The study lists 2 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 21 Apr 2023.