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Can this knee implant last a decade? study tracks outcomes

NCT ID NCT02211794

Symptom relief Sponsor: Smith & Nephew Orthopaedics AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are following people who receive the Journey II BCS total knee replacement to see how long the implant lasts and how it affects pain and daily life. The study enrolls adults with degenerative joint disease who need a primary knee replacement. Participants are monitored for 10 years, and the main measure is whether the implant survives without needing revision surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Journey II BCS total knee replacement system
What this could lead to
If the implant performs well over 10 years, it could give patients and surgeons more confidence when choosing a knee replacement for degenerative joint disease.
What could go wrong
This is an observational study without a comparison group, so it cannot prove the implant causes better outcomes. Results may not apply to all patients, and some implants may still need revision surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

179 people

The number who actually took part.

Started

Feb 2014

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

arthropathy avascular necrosis osteoarthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative joint disease

Contacts and locations

Locations

  • Martina Hansens Hospital

    Sandvika, Norway

  • North Hampshire Hospital

    Basingstoke, RG24 7AL, United Kingdom

  • Sint Maartenskliniek

    Nijmegen, 9500, Netherlands

  • UZ Gent

    Ghent, 9000, Belgium

  • University of Modena and Reggio Emilia

    Modena, 41124, Italy

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