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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02752581
Other study ID # TÜTFEK 2008/201
Secondary ID
Status Completed
Phase N/A
First received April 19, 2016
Last updated April 26, 2016
Start date January 2009
Est. completion date April 2013

Study information

Verified date April 2016
Source Trakya University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date April 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Suction drain
A suction drain is used to remove excess fluid from tissues after surgery.
No suction drain
A suction drain is used to remove excess fluid from tissues after surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mert Özcan

References & Publications (3)

Alkan K, Unay K, Berkem L, Güven 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. — View 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. — View Citation

Tatari H, Dervisbey M, Muratli K, Ergör 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. Epub 2004 Nov 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Amount of drainage The amount of fluid in suction drain. It is measured with cubic centimetre (cc). 1 day No
Other patellar shock 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 No
Primary 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. 3 months No
Primary 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. 3 months No
Primary Range of Motion Range of motion is measures in terms of angular degrees. 3 months Yes
Secondary Lysholm Lysholm is a scoring system from zero to one hundred. It measures subjective complaints of the patients. 3 months Yes
Secondary International Knee Documentation Committee Score is a scoring system from zero to one hundred. It measures subjective complaints of the patients. 3 months Yes
Secondary hospitalization time It is measured in days. It shows the period of hospitalization time, from surgery to discharge. 1 month No
Secondary loss of labour time It is measured in days. It shows the time from discharge to beginning of work. 1 month No
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