|- candidate number||19223|
|- NTR Number||NTR4709|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2014|
|- Secondary IDs||P1368 Reade METC |
|- Public Title||Flexion with the Journey II BCS TKA|
|- Scientific Title||Flexion with the Journey II BCS Total Knee System.
A Prospective, Non-randomized, Consecutive Series, Observational Study.|
|- ACRONYM||Flexion with Journey II|
|- hypothesis||When this new knee system will facilitate a high knee flexion, this will be depicted in a superior knee function. In addition, a high flexion ability will result in high clinical and functional outcome scores and high patient satisfaction.|
|- Healt Condition(s) or Problem(s) studied||Knee osteoarhritis, Total knee arthroplasty|
|- Inclusion criteria||•Patient presents with non-inflammatory knee osteoarthritis (radiologically confirmed), requiring total knee arthroplasty|
•Patient is 40 to 70 years of age, inclusive
•Patient plans to be available for follow-up through two years postoperative
•Patient is in stable health and is free of or treated for cardiac, pulmonary, haematological, or other conditions that would pose excessive operative risk
•Patient has <10 fixed (non-correctable) varus or valgus deformity
•Orthopaedic surgeon is member of the Knee Reconstruction Unit
|- Exclusion criteria||•Patient is known to have insufficient femoral or tibial bone stock|
•Patient has a BMI >35
•Patient’s expected physical activity after surgery is 2 or less on the UCLA Activity Scale
•Patient has had previous hip or knee replacement surgery in the last 6 months
•Patient is planned to have additional hip or contralateral knee replacement in the next 6 months
•Patient has had major, non-arthroscopic surgery to the study knee, including osteotomy around the knee
•Patient has an active, local infection or systemic infection
•Patient has physical, emotional or neurological conditions that would compromise compliance with postoperative rehabilitation and follow-up
•Patient has grade 3 collateral ligament insufficiency (complete tear of ligament)
•Patient has knee flexion <90
•Patient has fixed flexion deformity >20
•Patient has rheumatoid arthritis, any autoimmune disorder or immunosuppressive disorder
•Patient is pregnant or plans to become pregnant during course of study
•Patient has a known sensitivity to materials in the device and/or cutting blocks
•Patient has >30 extension deficit
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-mei-2017|
|- Target number of participants||62|
|- Interventions||The trial treatment is the Journey II BCS Total Knee System, which has been cleared for use by the FDA through the 510(k) process in the US and has been CE-marked in Europe. |
All patients will receive associated hospital preoperative, per-operative and postoperative standard care.
The Journey II BCS replacement procedures will be performed according to the recommended surgical technique described in the instructions for use as a means of preparing the bones for the implants. The instrumentation consist of femoral and tibial cutting blocks, placed with the use of intramedullary or extramedullary alignment rods. The Journey II BCS total knee system will be placed with the use of a tensioner and by means of a fully cemented femoral and tibial component. For this study, the patella must be resurfaced.
|- Primary outcome||Maximal passive knee flexion measured on a lateral X-ray one year after surgery.|
|- Secondary outcome||Clinical, functional and radiological performance as measured with: active flexion (lying and standing), KSS, EQ-5d, KOOS, Kujala, Forgotten Joint Score, VAS Satisfaction, number and type of Adverse Events, Hip-Knee-Ankle angle, Patellar tilt & displacement.|
|- Timepoints||pre-operative, 3 months, 12 months, 24 months.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Petra Heesterbeek|
|- CONTACT for SCIENTIFIC QUERIES|| Petra Heesterbeek|
|- Sponsor/Initiator ||Sint Maartenskliniek Nijmegen|
(Source(s) of Monetary or Material Support)
|Smith & Nephew|
|- Brief summary||Rationale: The Journey II BCS claims a renewed right to an active lifestyle by delivering unmatched function, motion and durability through natural motion in TKA. Natural motion will result into high flexion ability. The range of knee flexion and maximum knee flexion influences a patient’s ability to perform important activities of daily living and may therefore directly influence overall quality of life. When this new knee system will facilitate a high knee flexion, this will be depicted in a superior knee function. In addition, a high flexion ability will result in high clinical and functional outcome scores and high patient satisfaction.
Objective: The primary objective of the study is to investigate the maximal flexion ability of the Journey II BCS total knee system one year after surgery.
The secondary objective is to assess patient satisfaction, clinical, functional and radiological performance up to two years.
The ultimate goal is to compare the clinical and functional results of this cohort with the cohorts in the Journey I BCS and Genesis II RCT.
Study design: A prospective, non-randomized, consecutive series, observational study.
Statistical analysis: The primary outcome will be evaluated using descriptive statistics. Thereafter, the three cohorts will be compared using ANOVA.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in this study will not being barred by any additional risk other than the regular risks for a surgery of a primary TKA. The patients will visit the clinic at regular follow-up moments up to one year, and will receive a reimbursement for the two year visit. These visits take ±30 min extra than regularly because at these moments the patient visits also the research nurse for data collection. The questionnaires and physical examinations of the knee do not bring any extra burden. The additional radiographic assessment (long leg X-ray at 3 months and X-rays at two year visit) increases the total amount of radiation only slightly. However, the total amount of radiation falls within the limits of the ICRP (International Commission of Radiological Protection).
NOTE: some of the patients will additionally participate in a large sponsor-initiated European multi-centre observational safety and efficacy study.
|- Main changes (audit trail)|
|- RECORD||31-jul-2014 - 17-aug-2014|