Clinical Trials Register

Summary
EudraCT Number:	2013-001008-13
Sponsor's Protocol Code Number:	497
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-06-25
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2013-001008-13

A.3

Full title of the trial

Fast-track rehabilitation protocol for Total Knee Arthroplasty: A Randomized Controlled Trial comparing Local Infiltration Analgesia with Femoral Nerve Block

Fast track revalidatie protocol voor totale knieprothese: een gerandomizeerd onderzoek dat lokale infiltratie analgesie vergelijkt met femoralisblok

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparative study in patients receiving a total knee arthroplasty according to fast track protocol: local anesthesia of the knee verus anesthesia of the leg

Vergelijkende studie bij patienten die een knieprothese krijgen volgens de fast track procedure: lokale verdoving van de knie versus éénbeensverdoving

A.3.2

Name or abbreviated title of the trial where available

Fast track TKA: LIA vs FNB

A.4.1

Sponsor's protocol code number

497

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sint Maartenskliniek
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sint Maartenskliniek
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sint Maartenskliniek
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Hengstdal 3
B.5.3.2	Town/ city	Ubbergen
B.5.3.3	Post code	6574 NA
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31243659935
B.5.5	Fax number	+31243659317
B.5.6	E-mail	m.fenten@maartenskliniek.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ropivacaine HCl
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Periarticular use Perineural use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ropivacaine HCl
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Periarticular use Perineural use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	adrenaline CF
D.2.1.1.2	Name of the Marketing Authorisation holder	Centrafarm B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Periarticular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients requiring total knee arthroplasty for non-inflammatory osteoarthritis of the knee

patienten die een totale knie prothese ontvangen ivm gonarthrose

E.1.1.1

Medical condition in easily understood language

patients undergoing knee replacement surgery for osteoarthritis of the knee

patienten die een knieprothese krijgen ivm arthrose van de knie

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Identifying the optimal anesthesia technique for patients undergoing total knee arthroplasty according to the fast track protocol giving the best functional outcome

Vaststellen van de optimale anesthesietechniek voor patiënten die een totale knie prothese krijgen volgens fast track protocol die de beste functionele outcome geeft

E.2.2

Secondary objectives of the trial

Identifying the optimal anesthesia technique for patients undergoing total knee arthroplasty according to the fast track protocol in terms of: pain, used pain medication, quality, quantity and safety of in-hospital mobilization, patient satisfaction, time to reach discharge criteria, length of stay, patient reported functional outcome and quality of life.

Vaststellen van de optimale anesthesietechniek voor patiënten die een totale knie prothese krijgen volgens fast track protocol in het kader van: pijn, gebruikte pijnmedicatie, kwaliteit, kwantiteit en veiligheid van het mobiliseren gedurende opname, patienttevredenheid, tijd tot bereiken ontslagcriteria, opnameduur, functionele outcome volgens patient en kwaliteit van leven

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• age 50-80 years
• ASA physical health classification I – II
• patient presents with non-inflammatory primary knee osteoarthritis (radiological confirmation)
• patient planned for a primary unilateral posterior-stabilized tri-compartmental cemented total knee replacement (Genesis II - PS)
• scheduled for fast-track protocol TKA
• patient plans to be available for follow-up through one year postoperative
• written informed consent

leeftijd 50-80 jaar
ASA klasse I - II
non-inflammatoire gonartrose (rontgenologisch bevestigd)
op wachtlijst voor unilaterale primaire totale knieprothese (Genesis II PS) volgens fast track protocol
beschikbaar voor follow up gedurende een jaar post-operatief
getekende informed consent

E.4

Principal exclusion criteria

• any contra-indication for regional anesthesia
• any contra-indication for spinal anesthesia
• traumatic osteoarthritis requiring TKA
• an active, local infection or systemic infection
• known hypersensitivity to amide-type local anesthetics
• known hypersensitivity to opioids
• a Body Mass Index (BMI) > 40 kg/m2
• inability to walk independently (inability to walk at least 10 consecutive meters without a walking aid)
• scheduled for contralateral TKA within 1 year post-operative
• scheduled for another operation within 3 months post-operative
• physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
• chronic opioid analgesic therapy
• rheumatoid arthritis

contra-indicatie voor locoregionale anesthesie
contra-indicatie voor spinaalanesthesie
traumatische arthrose waarvoor TKP
actieve lokale of systemische infectie
overgevoeligheid voor lokaalanesthetica van het amide-type
overgevoeligheid voor opiaten
Body Mass Index (BMI) > 40 kg/m2
niet in staat zelfstandig 10 meter te lopen zonder hulpmiddelen (krukken, rollator, wandelstuk)
gepland voor ipsilaterale TKP binnen een jaar
gepland voor enige andere operatie binnen 3 maanden
fysieke, emotionele of neurologische conditie die de patient niet in staat stelt het fast track protocol en de follow up te volbrengen
chronisch opiatengebruik
reumatoide arthritis

E.5 End points

E.5.1

Primary end point(s)

Functional outcome will be measured with a performance battery consisting of three functional tests: the Timed-Up-And-Go test, the Stair Climbing Task and the Six Minute Walk test.

functionele outcome zal geweten worden met een set aan testen: de Timed-Up-And-Go test, de traplooptest en de 6 minuten looptest

E.5.1.1

Timepoint(s) of evaluation of this end point

The performance battery will be done pre-operative, at reaching hospital discharge criteria, 3 months post-operative and one year post-operative

De functionele testen worden afgenomen: pre-operatief, bij bereiken ontslagcriteria, 3 maanden postoperatief en één jaar postoperatief

E.5.2

Secondary end point(s)

NRS pain, used pain medication, quality of in-hospital mobilization by NRS given by the physical therapist, quantity of in-hospital mobilization measured with an accelerometer and safety of in-hospital mobilization by NRS given by the physical therapist, patient satisfaction with the analgesia (NRS), time to reach discharge criteria in days, length of stay in days, patient reported functional outcome using LEFS and Oxford12Q questionnaires and quality of life using the EQ5D questionnaire.

NRS pijn, gebruikte pijnmedicatie, kwaliteit van het mobiliseren gedurende opname vastgesteld door de fysiotherapeut (NRS), kwantiteit van het mobiliseren gedurende opname gemeten met een accelerometer en veiligheid van het mobiliseren gedurende opname vastgesteld door de fysiotherapeut, patienttevredenheid met de pijnbestrijding (NRS), tijd tot bereiken ontslagcriteria in dagen, opnameduur in dagen, functionele outcome volgens patient gemeten met de Oxford12Q vragenlijst en de LEFS vragenlijst en kwaliteit van leven gemeten met de EQ5D vragenlijst

E.5.2.1

Timepoint(s) of evaluation of this end point

Pre-operative, at reaching hospital discharge criteria, 6 weeks post-operative, 3 months post-operative and one year post-operative

pre-operatief, bij bereiken ontslagcriteria, 6 weken postoperatief, 3 maanden postoperatief en één jaar postoperatief

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

andere injectieplaats (femoralisblok versus lokale infiltratie)

other site of injection (femoral nerve block versus local infiltration)

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

laatste meting laatste proefpersoon

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

normal treatment of that condition will be provided

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-18

P. End of Trial
P.	End of Trial Status	Completed

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