Journey II BCS EU Observational Trial

N/AActive Not RecruitingNCT02211794

Smith & Nephew Orthopaedics AG175 enrolled

Overview

Post-market study to confirm the safety and efficacy of the Journey II BCS knee prosthesis.

Multicenter, prospective, observational study to collect relevant clinical data from 167 subjects implanted with the Journey II BCS Knee System. Data from eligible subjects, who have provided written informed consent for the collection of their coded data will be recorded from the patient's medical file on specially designed case report forms (CRF's). Total study duration for participants will be 10 years with follow-up visits planned at 3 months, 1 year, 2 years, 5 years and 10 years post-surgery. An interim analysis describing the clinical outcome is planned after 5 years.

Study Type

OBSERVATIONAL

Enrollment

175

Conditions

Degenerative Joint Disease

Interventions

data collectionOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria * subject requires primary total knee arthroplasty with the Journey II BCS Total Knee System, including patella resurfacing * subject requires primary total knee arthroplasty due to degenerative joint disease (primary osteoarthritis, post-traumatic arthritis, avascular necrosis, rheumatoid arthritis) * subject is of legal age to consent, agrees to consent to and to follow the study visit schedule, by signing the EC approved informed consent form Exclusion Criteria: * age \> 75 years * conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * subject has inadequate bone stock to support the device

Locations (5)

UZ Gent

Ghent, Belgium

University of Modena and Reggio Emilia

Modena, Italy

Sint Maartenskliniek

Nijmegen, Netherlands

Martina Hansens Hospital

Sandvika, Norway

North Hampshire Hospital

Outcomes

Primary Outcomes

Revision for any reason

The goal of this study is to confirm the safety and efficacy of the Journey II BCS knee prosthesis by demonstrating non-inferiority of the cumulative percent success in subjects implanted with the JOURNEY II BCS Total Knee System compared to a literature reference rate of 94.3% (AOA annual report 201121) at 10 years. "Success" is defined as 10 year survival of the study device without revision for any reason.

Time frame: 10Years

Secondary Outcomes

EQ-5D questionnaire

patient's opinion about his state of health, according to a visual analogue scale and 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression, (each dimension having 3 levels: no problems, some problems, extreme problems)

Time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr

Knee Pain Evaluation Form questionnaire

Assessment of post-operative knee pain

Time frame: 3month, 1yr, 2yr

2011 Knee Society Score

A clinical follow-up and patient satisfaction, patient's expectations and a self-assessment of the physical outcome

Time frame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr

radiographic evaluation

The Knee Society Total Knee Arthroplasty Roentographic Evaluation and Scoring System will be used to analyse radiographic findings at each visit.

Time frame: pre-op, discharge, 3month, 1yr, 5yr, 10yr

complication rate (adverse events and revisions)

complications will be assessed at each visit.

Time frame: discharge, 3month, 1yr, 2yr, 5yr, 10yr

Data from ClinicalTrials.gov

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