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

Total Knee Replacement Clinical Trial

— KTSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873637
• Other study ID #: CHD 065-16
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 11, 2018

Study information

• Verified date: June 2019
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Device:
• under sartorial catheter

• femoral catheter

Locations

Country	Name	City	State
France	CHD Vendée de la Roche sur Yon	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

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