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Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery

Primary Purpose

Chondropathy, Knee Effusion, Knee Hemarthrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suction drain
No suction drain
Sponsored by
Mert Özcan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chondropathy focused on measuring suction drain, knee arthroscopy, knee pain

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Drain Group

    Control Group

    Arm Description

    Suction drain was applied to these patients after arthroscopic knee surgery.

    No suction drain was applied to this group, therefore used as a control group.

    Outcomes

    Primary Outcome Measures

    Activity Pain
    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.
    Rest Pain
    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.
    Range of Motion
    Range of motion is measures in terms of angular degrees.

    Secondary Outcome Measures

    Lysholm
    Lysholm is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
    International Knee Documentation Committee Score
    is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
    hospitalization time
    It is measured in days. It shows the period of hospitalization time, from surgery to discharge.
    loss of labour time
    It is measured in days. It shows the time from discharge to beginning of work.

    Full Information

    First Posted
    April 19, 2016
    Last Updated
    April 26, 2016
    Sponsor
    Mert Özcan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02752581
    Brief Title
    Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
    Official Title
    Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mert Özcan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chondropathy, Knee Effusion, Knee Hemarthrosis
    Keywords
    suction drain, knee arthroscopy, knee pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Care ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drain Group
    Arm Type
    Other
    Arm Description
    Suction drain was applied to these patients after arthroscopic knee surgery.
    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    No suction drain was applied to this group, therefore used as a control group.
    Intervention Type
    Device
    Intervention Name(s)
    Suction drain
    Other Intervention Name(s)
    Hemovac drain
    Intervention Description
    A suction drain is used to remove excess fluid from tissues after surgery.
    Intervention Type
    Device
    Intervention Name(s)
    No suction drain
    Intervention Description
    A suction drain is used to remove excess fluid from tissues after surgery.
    Primary Outcome Measure Information:
    Title
    Activity Pain
    Description
    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.
    Time Frame
    3 months
    Title
    Rest Pain
    Description
    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.
    Time Frame
    3 months
    Title
    Range of Motion
    Description
    Range of motion is measures in terms of angular degrees.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Lysholm
    Description
    Lysholm is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
    Time Frame
    3 months
    Title
    International Knee Documentation Committee Score
    Description
    is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
    Time Frame
    3 months
    Title
    hospitalization time
    Description
    It is measured in days. It shows the period of hospitalization time, from surgery to discharge.
    Time Frame
    1 month
    Title
    loss of labour time
    Description
    It is measured in days. It shows the time from discharge to beginning of work.
    Time Frame
    1 month
    Other Pre-specified Outcome Measures:
    Title
    Amount of drainage
    Description
    The amount of fluid in suction drain. It is measured with cubic centimetre (cc).
    Time Frame
    1 day
    Title
    patellar shock
    Description
    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.
    Time Frame
    1.5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with knee derangement and accepted to enroll to the study Exclusion Criteria: intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    711799
    Citation
    Browett JP, Gibbs AN, Copeland SA, Deliss LJ. The use of suction drainage in the operation of meniscectomy. J Bone Joint Surg Br. 1978 Nov;60-B(4):516-9. doi: 10.1302/0301-620X.60B4.711799.
    Results Reference
    background
    PubMed Identifier
    21908960
    Citation
    Alkan K, Unay K, Berkem L, Guven M, Poyanli O. Suction drainage influence on knee effusion following partial meniscectomy with partial fat pad or synovium resection. Acta Orthop Traumatol Turc. 2011;45(4):221-4. doi: 10.3944/AOTT.2011.2545.
    Results Reference
    background
    PubMed Identifier
    16170580
    Citation
    Tatari H, Dervisbey M, Muratli K, Ergor A. Report of experience in 190 patients with the use of closed suction drainage in arthroscopic knee procedures. Knee Surg Sports Traumatol Arthrosc. 2005 Sep;13(6):458-62. doi: 10.1007/s00167-004-0537-1. Epub 2004 Nov 13.
    Results Reference
    background

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    Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery

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