Clinical Trials Directory

Trials / Terminated

TerminatedNCT02648971

Controlled Trial to Compare Single Versus Two Portal Knee Arthroscopy Techniques

A Randomized Controlled Trial to Compare Single Portal Versus Two Portal Knee Arthroscopy Techniques in Patients With Meniscal Injuries and Articular Cartilage Pathology

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
21 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This randomized, controlled clinical trial will compare the outcomes of single portal versus two portal techniques in patients who have meniscus or articular cartilage pathology. The study hypothesis is that patients who undergo single portal arthroscopy will have less pain post-operatively, use less pain medication, and have a higher International Knee Documentation Committee (IKDC) score at six months and one year compared to patients who undergo traditional two portal knee arthroscopy.

Detailed description

Background, Rationale and Context Knee arthroscopy procedures provide a minimally invasive method to assess the status of the knee joint in order to repair injuries of the meniscus and articular cartilage. In the past, two or more small openings in the skin (portals) were required in order to allow the passage of both an arthroscope to provide visualization of the knee joint and the instrument used to complete the surgical repair process. However, recent innovations in arthroscopy instrumentation have resulted in the ability to use one portal for knee arthroscopy procedures with both the arthroscope and the instruments passed into the knee joint through the same portal. Both uniportal and two portal arthroscopic techniques are used currently for knee arthroscopy procedures in the Department of Orthopaedic Surgery at Wake Forest Baptist Health. Objectives This randomized, controlled clinical trial will compare the outcomes of single portal versus two portal techniques in patients who have meniscus or articular cartilage pathology. The study hypothesis is that patients who undergo single portal arthroscopy will have less pain post-operatively, use less pain medication, and have a higher International Knee Documentation Committee (IKDC) score at six months and one year compared to patients who undergo traditional two portal knee arthroscopy. Methods and Measures Design: A randomized, controlled trial Setting: Academic Medical Center: single study site at Wake Forest Baptist Health

Conditions

Interventions

TypeNameDescription
PROCEDURESingle Portal Knee ArthroscopyPatients in Group 1 will undergo knee arthroscopy using a single portal.
PROCEDURETwo Portal Knee ArthroscopyPatients in Group 2 will undergo knee arthroscopy using two portals.

Timeline

Start date
2016-01-01
Primary completion
2018-05-31
Completion
2018-05-31
First posted
2016-01-07
Last updated
2020-12-30
Results posted
2020-12-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02648971. Inclusion in this directory is not an endorsement.