Sutures for Treatment of Knee Arthroscopy

NCT05822973 | Completed FDA Device

• 1 other identifier: KFRE18D.721
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroscopy; Suture

Outcome Measures

Primary Outcomes (2)

• Postoperative Pain Leveles

  Pain levels will be recorded through the Visual Analogue Scale (VAS)

  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

  3 months

Study Arms (2)

would closure using absorbable sutures

ACTIVE COMPARATOR

patients randomized into the absorbable suture group will have their incisions closed with 3.0 monocryl sutures

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

Device: 3.0 nylon suture

Interventions

3.0 monocryl suture DEVICE

incision will be closed with absorbable suture

would closure using absorbable sutures

3.0 nylon suture DEVICE

incision will be closed with non-absorbable suture

would closure using non-absorbable sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: November 18, 2018
• Primary Completion: April 9, 2023
• Study Completion: April 9, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (1)