Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement (KTSS)

June 14, 2019 updated by: Centre Hospitalier Departemental Vendee

Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement: A Controlled, Randomized Study (KTSS)

The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.

Patients will be randomized in two arms:

  • catheter in position under sartorial (experimental group)
  • femoral catheter (control group)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche sur Yon, France, 85925
        • CHD Vendée de la Roche sur Yon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major Patient (≥ 18 years)
  • Before tricompartmental benefit from knee replacement (TKR) unilateral,
  • TKR programmed on one of the first three days of the week (Monday to Wednesday)
  • Physical status score I-III,
  • Non septic programmed surgery under general anesthesia
  • Able to understand the protocol
  • Written informed consent
  • Social Insured
  • Opportunity to be followed under the Protocol

Exclusion Criteria:

  • Age ≥ 85 years
  • Obesity (BMI ≥ 35)
  • Revision TKR,
  • Patients not cooperating or not including the French,
  • Difficulties in understanding and evaluating the score pain (VAS),
  • Preoperative cognitive dysfunction making unreliable interrogation
  • Patient unable to read and / or write (literacy, ...)
  • Known bleeding disorders,
  • Vascular surgery for femoral vessels on the operated side,
  • Neuropathy of the lower limb,
  • Localized infection at the puncture catheters,
  • Known allergy to ropivacaine,
  • Renal and / or severe hepatic impairment,
  • Taking opioids for more than a month before surgery,
  • Intolerance to morphine,
  • Rheumatic inflammatory disease,
  • Patients receiving immunosuppressive therapy or long-term corticosteroid
  • Allergy or against-indications to standard treatments administered intraoperative and postoperative
  • Flexion deformity> 10 ° or valgus deformity with significant
  • Refused to participate
  • Patient trusteeship, guardianship, deprived of liberty
  • Women premenopausal who become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: under sartorial catheter
catheter under sartorial
Device: under sartorial catheter
Other: femoral catheter
Device: femoral catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International clinical score Daniels and Worthingham
Time Frame: 2 day after surgery (total knee replacement)
This score measures the driving force of the quadriceps (scale M0: no contraction in M5: normal force)
2 day after surgery (total knee replacement)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

September 11, 2018

Study Completion (Actual)

November 11, 2018

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHD 065-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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