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Completed

NCT Number: NCT02752581

Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery

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.

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Key information

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Suction drain

Device

A suction drain is used to remove excess fluid from tissues after surgery.

Other names: Hemovac drain

No suction drain

Device

A suction drain is used to remove excess fluid from tissues after surgery.

Primary outcomes

  1. 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.

  2. 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. Range of Motion

    Time frame: 3 months

    Range of motion is measures in terms of angular degrees.

Secondary outcomes

  1. Lysholm

    Time frame: 3 months

    Lysholm is a scoring system from zero to one hundred. It measures subjective complaints of the patients.

  2. 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. hospitalization time

    Time frame: 1 month

    It is measured in days. It shows the period of hospitalization time, from surgery to discharge.

  4. loss of labour time

    Time frame: 1 month

    It is measured in days. It shows the time from discharge to beginning of work.

Other outcomes

  1. Amount of drainage

    Time frame: 1 day

    The amount of fluid in suction drain. It is measured with cubic centimetre (cc).

  2. 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.

Sponsors and collaborators

Lead sponsor

Mert Özcan

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Apr 27, 2016
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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