Clinical trial NCT02211794: Journey II BCS EU Observational Trial
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Degenerative Joint Disease
Keywords: Total Knee Arthroplasty
degenerative joint disease
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-07
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a patient population consisting of 150 cases and recruited from 4 different countries, will be followed up when undergoing TKA as part of their standard care

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Revision for any reason
timeFrame: 10Years
Secondary outcomes:
measure: EQ-5D questionnaire
timeFrame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
measure: Knee Pain Evaluation Form questionnaire
timeFrame: 3month, 1yr, 2yr
measure: 2011 Knee Society Score
timeFrame: pre-op, 3month, 1yr, 2yr, 5yr, 10yr
measure: radiographic evaluation
timeFrame: pre-op, discharge, 3month, 1yr, 5yr, 10yr
measure: complication rate (adverse events and revisions)
timeFrame: discharge, 3month, 1yr, 2yr, 5yr, 10yr
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
city: Basingstoke
country: United Kingdom
facility: North Hampshire Hospital
Study officials:
affiliation: North Hampshire Hospital
name: Mike Risebury, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Modena and Reggio Emilia
name: Fabio Catani, Prof
role: STUDY_CHAIR
affiliation: UZ Ghent
name: Jan Victor, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint-Maartenskliniek Nijmegen
name: Gijs Van Hellemondt
role: PRINCIPAL_INVESTIGATOR
affiliation: Martina Hansens Hospital
name: Stig Heir
role: PRINCIPAL_INVESTIGATOR
References: