Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery

April 26, 2016 updated by: Mert Özcan
The study was designed to investigate efficacy of suction drains in arthroscopic knee surgery, rather than anterior cruciate ligament (ACL) reconstruction. two groups were randomised, and suction drain was applied to one group, and the other group as the control group without a suction drain.

Study Overview

Detailed Description

The groups were compared in terms of patellar shock, knee effusion, knee scoring systems, range of motion, loss of labour, hospitalization time. Also different arthroscopic procedures such as meniscectomy, meniscus repair, synovectomy and microfracture were evaluated in terms of need for a suction drain. The controls was at 1st and 15th day, 6th week and 3rd month.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

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

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with knee derangement and accepted to enroll to the study

Exclusion Criteria:

  • intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Drain Group
Suction drain was applied to these patients after arthroscopic knee surgery.
A suction drain is used to remove excess fluid from tissues after surgery.
Other Names:
  • Hemovac drain
Other: Control Group
No suction drain was applied to this group, therefore used as a control group.
A suction drain is used to remove excess fluid from tissues after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity Pain
Time Frame: 3 months
Severity of pain was evaluated with Visual Analogue Scale (VAS). VAS is a horizontal line divided into ten equal intervals in which zero represents no pain and 10 represents the worst pain ever felt.
3 months
Rest Pain
Time Frame: 3 months
Severity of pain was evaluated with Visual Analogue Scale (VAS). VAS is a horizontal line divided into ten equal intervals in which zero represents no pain and 10 represents the worst pain ever felt.
3 months
Range of Motion
Time Frame: 3 months
Range of motion is measures in terms of angular degrees.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm
Time Frame: 3 months
Lysholm is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
3 months
International Knee Documentation Committee Score
Time Frame: 3 months
is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
3 months
hospitalization time
Time Frame: 1 month
It is measured in days. It shows the period of hospitalization time, from surgery to discharge.
1 month
loss of labour time
Time Frame: 1 month
It is measured in days. It shows the time from discharge to beginning of work.
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of drainage
Time Frame: 1 day
The amount of fluid in suction drain. It is measured with cubic centimetre (cc).
1 day
patellar shock
Time Frame: 1.5 months
Patellar shock was graded in four scales: Grade 1, some notable fluid, Grade 2, minimally elevated patella, Grade 3, patellar ballottement, and Grade 4, tense knee capsule, unable to compress patella.
1.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

January 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • TÜTFEK 2008/201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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