- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752581
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
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.
General Publications
- 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.
- 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.
- 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.
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
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Chondropathy
-
Istituto Ortopedico RizzoliCompletedKnee Chondropathy | Knee Early OsteoarthritisItaly
-
The Catholic University of KoreaCompletedDegenerative Chondropathy | Early OsteoarthritisKorea, Republic of
-
Medical University of WarsawNot yet recruitingKnee Osteoarthritis | Chondropathy
-
Istituto Ortopedico RizzoliCompletedOsteoarthritis, Knee | Knee ChondropathyItaly
-
The Hawkins FoundationFerring PharmaceuticalsTerminatedMeniscus Tear | Chondropathy/Degenerative Joint Disease (DJD)United States
Clinical Trials on Suction drain
-
Assiut UniversityCompleted
-
Shifa International HospitalCompletedPain | Surgery | Acute Cholecystitis | Morbidity, Multiple | Drain Site ComplicationPakistan
-
Oslo University HospitalCompletedEarly Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma PatientsMelanoma | ComplicationNorway
-
Centre hospitalier de l'Université de Montréal...WithdrawnHead and Neck Neoplasms | Drain Site Complication | Neck Dissection
-
University of ArizonaUnknown
-
University Hospital FreiburgCompletedDigestive System Diseases [C06] | Digestive System Neoplasms [C04.588.274]Germany
-
University of RegensburgCompleted
-
Ain Shams Maternity HospitalCompleted
-
University Hospital Hradec KraloveCompletedPancreaticoduodenectomy | Distal PancreatectomyCzech Republic
-
Turku University HospitalKarolinska Institutet; Kuopio University HospitalCompletedAdolescent Idiopathic ScoliosisSweden, Finland