Sutures for Treatment of Knee Arthroscopy

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Completed

CT.gov ID

NCT05822973

Collaborator

(none)

274

Enrollment

Location

Arms

52.7

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Knee Arthroscopy Suture	Device: 3.0 monocryl suture Device: 3.0 nylon suture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

274 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Absorbable Versus Nonabsorbable Sutures for the Treatment of Knee Arthroscopy: A Prospective Comparison of Patient Outcomes and Satisfaction

Actual Study Start Date :

Nov 18, 2018

Actual Primary Completion Date :

Apr 9, 2023

Actual Study Completion Date :

Apr 9, 2023

Arms and Interventions

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	Device: 3.0 monocryl suture 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	Device: 3.0 nylon suture incision will be closed with non-absorbable suture

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

Device: 3.0 monocryl suture

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

Device: 3.0 nylon suture

incision will be closed with non-absorbable suture

Outcome Measures

Primary Outcome Measures

Postoperative Pain Leveles [3 months]
Pain levels will be recorded through the Visual Analogue Scale (VAS)
Patient Satisfaction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT05822973

Other Study ID Numbers:

KFRE18D.721

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Apr 21, 2023