Total Knee ReplacementKTSSNCT02873637
Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement
A study testing under sartorial catheter and femoral catheter in people with Total Knee Replacement, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- under sartorial catheter and femoral catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 11 Nov 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Written informed consent
- Social Insured
- Opportunity to be followed under the Protocol
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)
- Conditions
- Total Knee Replacement
- Being tested
- under sartorial catheter, femoral catheter
- Keywords
- total knee replacement, anesthesia, catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
under sartorial catheterDevice
femoral catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| under sartorial catheter | Experimental | catheter under sartorial Receives: Device: under sartorial catheter |
| femoral catheter | Other | femoral catheter Receives: Device: femoral catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
International clinical score Daniels and Worthingham
This score measures the driving force of the quadriceps (scale M0: no contraction in M5: normal force)
Measured: 2 day after surgery (total knee replacement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startJan 2017
- Primary completion11 Sep 2018
- Study completion11 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873637
- Sponsor's protocol ID
- CHD050-16
- Acronym
- KTSS
- Status last verified
- Nov 2025
- First submitted
- 12 Aug 2016
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Guilley J, Besancon I, Hivert A, Plouhinec AM, Oudot M, Venet G, Fraquet N, Cousin J, Planche L, Ganiere C, Duchalais A. Femoral nerve inguinal approach versus proximal femoral triangle ap proach for continuous regional analgesia in active rehabilitation after total knee arthroplasty: A prospective, randomised study. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101043. doi: 10.1016/j.accpm.2022.101043. Epub 2022 Feb 19.
PubMed 35189397
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02873637
- Acronym / sponsor ID
- KTSS / CHD050-16
- Conditions
- Total Knee Replacement
- Keywords
- total knee replacement, anesthesia, catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Nov 2018 (actual)
- First posted
- 19 Aug 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| under sartorial catheter | Experimental | Device: under sartorial cathetercatheter under sartorial |
| femoral catheter | Other | Device: femoral catheterfemoral catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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),
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 |
|---|---|---|
| under sartorial catheter | Device | under sartorial catheter |
| femoral catheter | Device | femoral catheter |
Primary outcome
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)
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 4 Dec 2025.
- Results publication: PubMed 35189397Guilley J, Besancon I, Hivert A, Plouhinec AM, Oudot M, Venet G, Fraquet N, Cousin J, Planche L, Ganiere C, Duchalais A. Femoral nerve inguinal approach versus proximal femoral triangle ap proach for continuous regional analgesia in active rehabilitation after total knee arthroplasty: A prospective, randomised study. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101043. doi: 10.1016/j.accpm.2022.101043. Epub 2022 Feb 19.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing under sartorial catheter and femoral catheter in people with Total Knee Replacement, run by Centre Hospitalier Departemental Vendee at 1 site in France.
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 9 inclusion and 22 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
International clinical score Daniels and Worthingham (time frame: 2 day after surgery (total knee replacement)). 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 NCT02873637, which also lists 1 linked publication.
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 4 Dec 2025.