ChondropathyNCT02752581
Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
A study testing Suction drain and No suction drain in people with Chondropathy and Knee Effusion, run by Mert Özcan.
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. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Chondropathy, Knee Effusion, Knee Hemarthrosis
- What is being tested?
- Suction drain and No suction drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with knee derangement and accepted to enroll to the study
Who cannot join
- intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,
About this study
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.
Read the 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.
- Conditions
- Chondropathy, Knee Effusion, Knee Hemarthrosis
- Being tested
- Suction drain, No suction drain
- Keywords
- suction drain, knee arthroscopy, knee pain
- Medical subject headings
- Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suction drainDevice
Also called Hemovac drain
A suction drain is used to remove excess fluid from tissues after surgery.
No suction drainDevice
A suction drain is used to remove excess fluid from tissues after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Drain Group | Other | Suction drain was applied to these patients after arthroscopic knee surgery. Receives: Device: Suction drain |
| Control Group | Other | No suction drain was applied to this group, therefore used as a control group. Receives: Device: No suction drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Range of Motion
Range of motion is measures in terms of angular degrees.
Measured: 3 months
Secondary outcomes (4)
Lysholm
Lysholm is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
Measured: 3 months
International Knee Documentation Committee Score
is a scoring system from zero to one hundred. It measures subjective complaints of the patients.
Measured: 3 months
hospitalization time
It is measured in days. It shows the period of hospitalization time, from surgery to discharge.
Measured: 1 month
loss of labour time
It is measured in days. It shows the time from discharge to beginning of work.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ChondropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mert Özcan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mert Özcan, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752581
- Sponsor's protocol ID
- TÜTFEK 2008/201
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 711799Alkan 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.
PubMed 21908960Tatari 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.
PubMed 16170580
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Peroperative Suction Drain Usage in Arthroscopic Knee Surgery
- ClinicalTrials.gov ID
- NCT02752581
- Acronym / sponsor ID
- TÜTFEK 2008/201
- Conditions
- Chondropathy, Knee Effusion, Knee Hemarthrosis
- Keywords
- suction drain, knee arthroscopy, knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mert ÖzcanUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain Group | Other | Device: Suction drainSuction drain was applied to these patients after arthroscopic knee surgery. |
| Control Group | Other | Device: No suction drainNo suction drain was applied to this group, therefore used as a control group. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with knee derangement and accepted to enroll to the study
Key exclusion criteria (1 listed)
- intraarticular fracture, ACL surgery, arthrotomy, bleeding disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suction drainAlso: Hemovac drainA suction drain is used to remove excess fluid from tissues after surgery. | Device | Drain Group |
| No suction drainA suction drain is used to remove excess fluid from tissues after surgery. | Device | Control Group |
Primary outcome
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.
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.
Range of Motion
Time frame: 3 months
Range of motion is measures in terms of angular degrees.
4 secondary outcomes
Lysholm
Time frame: 3 months
International Knee Documentation Committee Score
Time frame: 3 months
hospitalization time
Time frame: 1 month
loss of labour time
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Background: PubMed 711799Browett 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.
- Background: PubMed 21908960Alkan 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.
- Background: PubMed 16170580Tatari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Suction drain and No suction drain in people with Chondropathy and Knee Effusion, run by Mert Özcan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity Pain (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752581, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.