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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Single Portal Knee Arthroscopy | Patients in Group 1 will undergo knee arthroscopy using a single portal. |
| PROCEDURE | Two Portal Knee Arthroscopy | Patients 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.