NCT02752581

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
Last Updated

April 27, 2016

Status Verified

April 1, 2016

Enrollment Period

3.9 years

First QC Date

April 19, 2016

Last Update Submit

April 26, 2016

Conditions

ChondropathyKnee EffusionKnee Hemarthrosis

Keywords

suction drainknee arthroscopyknee pain

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Range of Motion

    Range of motion is measures in terms of angular degrees.

    3 months

Secondary Outcomes (4)

  • Lysholm

    3 months

  • International Knee Documentation Committee Score

    3 months

  • hospitalization time

    1 month

  • loss of labour time

    1 month

Other Outcomes (2)

  • Amount of drainage

    1 day

  • patellar shock

    1.5 months

Study Arms (2)

Drain Group

OTHER

Suction drain was applied to these patients after arthroscopic knee surgery.

Device: Suction drain

Control Group

OTHER

No suction drain was applied to this group, therefore used as a control group.

Device: No suction drain

Interventions

Suction drainDEVICE

A suction drain is used to remove excess fluid from tissues after surgery.

Also known as: Hemovac drain
Drain Group
No suction drainDEVICE

A suction drain is used to remove excess fluid from tissues after surgery.

Control Group

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 711799BACKGROUND

  • 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.

    PMID: 21908960BACKGROUND

  • 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.

    PMID: 16170580BACKGROUND

MeSH Terms

Conditions

Cartilage Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 27, 2016

Study Start

January 1, 2009

Primary Completion

December 1, 2012

Study Completion

April 1, 2013

Last Updated

April 27, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share