European Journey II BCS Safety and Efficacy study; Protcl.°:R11009-7
Research type
Research Study
Full title
A Prospective, Non-randomized, Consecutive Series, Multicenter, Observational Trial to Evaluate the Clinical Outcome of Total Knee Arthroplasty Using Journey II BCS Total Knee System.
IRAS ID
110813
Contact name
Michael Risebury
Contact email
Sponsor organisation
Smith & Nephew nv
Clinicaltrials.gov Identifier
Research summary
Smith & Nephew has initiated this study to evaluate the safety and efficacy of the Journey II BCS knee prosthesis: how well is its performance and to which extent do adverse events occur?
The careful follow up of the knee joint following the total knee replacement will occur in its usual manner. This means that the patient will need to come back to the hospital for a routine clinical assessment and an X-ray at specific time points (at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery). During these follow-up visits, the surgeon will document to which extent the knee joint recovers its functionality (for example, to which extent can the patient bend and stretch his/her knee?). And, pre-operatively as well as at the 3 month, 1 year, 5 year and 10 year post-operative follow-up visits, the physician will evaluate the X-rays which will be taken from the knee.
All the above is standard clinical practice. If the patient decides to participate in this study however, his/her medical data related to your knee surgery will be coded and transferred to Smith and Nephew.The patient will also be asked to complete a set of questionnaires. On these questionnaires the patient will need to assess any possible residual knee pain or stiffness (s)he may still experience after the knee surgery, the influence this may have on his/her daily activities and to which extent the surgery has met his/her expectations towards the clinical result.
Thanks to the fact that several surgeons will be collecting the same data from approximately 167 patients, it can be evaluated to which extent this prosthesis is safe and efficient.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0073
Date of REC Opinion
24 Feb 2014
REC opinion
Further Information Favourable Opinion