Back to resultsEfficacy 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
About this trial
This is an interventional treatment trial for Chondropathy focused on measuring suction drain, knee arthroscopy, knee pain
Eligibility Criteria
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
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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