NCT02375945

Brief Summary

Swelling is a common problem after knee arthroplasty often leading to delayed wound healing, lasting functional impairment and hematoma. Due to this complications, sometimes the risk for deep venous thrombosis is raised. This study investigates a new self adjustable device to reduce swelling more effective postoperatively. The investigators compare the new device to the current general practice by using a standard class 1 elastic stocking

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

February 7, 2015

Last Update Submit

September 26, 2016

Conditions

Lymphedema

Keywords

lymphedemapost operative compression treatmentcompression therapyadjustable fulcro wrapsedema

Outcome Measures

Primary Outcomes (2)

  • efficacy of the device on wound healing, swelling reduction and functional improvement

    efficacy of the device on wound healing, swelling reduction and functional improvement

    12 weeks

  • circumference measurements

    efficacy of the device

    12 weeks

Secondary Outcomes (1)

  • comfort to the patient / QoL

    12 weeks

Study Arms (2)

current compression stocking Comprinet®

ACTIVE COMPARATOR

Immediately post operatively 24 hours compression therapy starts with "Elastomull Haft ®", an elastic bandage, combined with a Comprinet stocking (BSM Medical®) for anti thrombotic purposes. The anti thrombosis stocking is worn 6 weeks post operatively. After 4 hours the patient is ambulated and the physical therapy starts.

Device: New non-elastic compression kitDevice: current compression stocking Comprinet®

New non-elastic compression kit

EXPERIMENTAL

Juxta Reduction Kit ® Immediately post operative compression starts with the Juxta Reduction Kit® for the knee region, combined with an anti thrombosis stocking (Struva 2, for prevention of trombo-embolism). Both the stocking and the Juxtra Pro are used for six weeks. After 4 hours the patient ambulated and the physical therapy starts. For the first 24 hours and longer if necessary (depending on the skills of the patient) Juxta experienced staff will apply the device and the fit and the use of the device will be checked. In the second phase between approximately 24 hours and 6 weeks patients may adjust the Juxta-pro according to their needs and comfort by themselves.

Device: New non-elastic compression kitDevice: current compression stocking Comprinet®

Interventions

New non-elastic compression kitDEVICE

Comparison of new non-elastic bandage kit with the currently accepted method

Also known as: study material
New non-elastic compression kitcurrent compression stocking Comprinet®
current compression stocking Comprinet®DEVICE

Comparison of new non-elastic bandage kit with the currently accepted method

New non-elastic compression kitcurrent compression stocking Comprinet®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Patients undergoing a primary elective total knee arthroplasty
  • The patient is able to understand the study and is willing to give written informed consent to the study.

You may not qualify if:

  • Allergy against one of the used materials
  • Severe systemic diseases causing peripheral oedema
  • Acute superficial or deep vein thrombosis
  • Arterial occlusive disease (stadium II, III or IV) ABPI\<0,8
  • Local infection in the therapy area
  • auto-immunological disorders or vasculitis
  • use of systemic corticosteroids
  • Inability to don, doff, and adjust the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nij Smellinghe hospital

Drachten, Provincie Friesland, 9202 NN, Netherlands

Location

MeSH Terms

Conditions

LymphedemaEdema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 7, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

NL(1)