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

Conditions: patients requiring total knee arthroplasty for non-inflammatory osteoarthritis of the knee
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2013-001008-13-NL

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Identifying the optimal anesthesia technique for patients undergoing total knee arthroplasty according to the fast track protocol giving the best functional outcome;Secondary Objective: 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. ;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.;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

Secondary Outcome Measures

Name	Time	Method
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. ;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