- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822973
Sutures for Treatment of Knee Arthroscopy
April 10, 2023 updated by: Rothman Institute Orthopaedics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
274
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Orthopaedic Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: would closure using absorbable sutures
patients randomized into the absorbable suture group will have their incisions closed with 3.0 monocryl sutures
|
incision will be closed with absorbable suture
|
Active Comparator: would closure using non-absorbable sutures
Patients randomized into the nonabsorbable suture group will have their incisions closed with either a 3.0 nylon suture
|
incision will be closed with non-absorbable suture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative Pain Leveles
Time Frame: 3 months
|
Pain levels will be recorded through the Visual Analogue Scale (VAS)
|
3 months
|
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
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2018
Primary Completion (Actual)
April 9, 2023
Study Completion (Actual)
April 9, 2023
Study Registration Dates
First Submitted
April 10, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KFRE18D.721
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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