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New knee implant aims to improve mobility for arthritis patients

NCT ID NCT02440672

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a new knee replacement system, the JOURNEY™ II CR, works for people with knee osteoarthritis. About 170 adults aged 22 to 75 who need a total knee replacement will receive the implant. Researchers will measure knee movement, survival of the implant, and quality of life over up to 10 years.

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

170 people

The number who actually took part.

Start date

Sep 2015

Expected to finish

Jun 2028

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

Subjects who present with DJD of the knee will be screened to determine if they meet all inclusion and no exclusion criteria. If all entry criteria are achieved, the subject will be eligible to participate in the study. All general and indication-specific entry criteria must be met prior to study entry.

Ages

22 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Subjects MUST meet ALL of the following criteria for inclusion in the study: 1. Has signed the IRB/EC approved ICF specific to this study prior to study participation 2. Is a male or female ≥ 22 and ≤ 75 years of age presenting with degenerative joint disease (DJD) of the knee 3. Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following: * Post-traumatic arthritis * Osteoarthritis * Degenerative arthritis 4. Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral) 5. Is in general good health (as determined by the Investigator) based on screening assessments and medical history 6. Is independent, ambulatory, and can comply with all post-operative evaluations 7. plans to be available through ten (10) years post-operative follow-up Exclusion Criteria: 1\. Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria: * Any of the following conditions in the index joint: * does not require patella resurfacing * has received a TKA or unicondylar arthroplasty * has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis) * Any of the following conditions in the contralateral joint: * has enrolled in the study for the contralateral knee * has received TKA as a revision for a failed total or unicondylar knee arthroplasty * has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator * Any of the following conditions of the hip: * received contralateral or ipsilateral revision hip arthroplasty * has ipsilateral hip arthritis resulting in flexion contracture * has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator * Has diagnosis of an immunosuppressive disorder * Has presence of malignant tumor, metastatic, or neoplastic disease * Has family history of severe osteoporosis/osteopenia * Has a known allergy to study device or one or more of its components * Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * Is receiving medication for the diagnosis of fibromyalgia * has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture) * Is pregnant or plans to become pregnant during the study * Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator * Has a BMI \> 40 * Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment * Is currently involved in personal injury litigation or a worker's compensation claim * Is facing current or impending incarceration * Is known to be at risk for lost to follow-up, or failure to return for scheduled visits

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Anne Arundel Health System Research Institute, Inc

    Annapolis, Maryland, 21401, United States

  • Barts Health NHS Trust

    Whitechapel, United Kingdom

  • Center for Hip and Knee Replacement at Columbia University Medical Center

    New York, New York, 10032, United States

  • Hospital Parc Taulí Servei de Cirurgia Ortopèdica I Traumatologia

    Barcelona, Spain

  • Orthopedic Institute of the West

    Phoenix, Arizona, 85054, United States

  • Royal National Orthopaedic Hospital NHS Trust

    Stanmore, United Kingdom

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • The Lindner Research Center, Musculo-Skeletal Division - The Christ Hospital Health Network

    Cincinnati, Ohio, 45219, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.