Chondropathy Clinical Trial
Official title:
Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
Verified date | April 2016 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics Committee |
Study type | Interventional |
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.
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, |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mert Özcan |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04675359 -
Adipose-derived MSCs After Enzymatic Digestion vs. Mechanically Fragmented Fat Transfer in Knee Osteoarthritis Treatment
|
Phase 4 |