Osteoarthritis Trial, Recruiting NCT04848896 Sponsor: Smith & Nephew, Inc. Condition: Osteoarthritis
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Osteoarthritis Trial, Recruiting

NCT04848896
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a suitable candidate for a total knee replacement surgery using a specific robotic surgical system (CORI) and a matching Smith+Nephew knee implant.
  • You need a cemented total knee replacement as your main treatment for one of the following: osteoarthritis or other non-inflammatory joint disease, rheumatoid arthritis, bone tissue death (avascular necrosis), a joint deformity that needs correcting, or a fracture that could not be treated another way.
  • You are 18 years of age or older at the time of surgery.
  • You agree to sign a consent form and follow the study's scheduled visit plan.
  • You are able to attend follow-up appointments for up to two years after your surgery.
  • Standard X-rays of your knee can be taken as part of the study.

Who may not be able to join:

  • You need a knee replacement to replace or fix a previous knee surgery that did not work, or you need a more complex type of implant rather than a standard one.
  • You have been diagnosed with arthritis caused by a past injury (post-traumatic arthritis).
  • You are having certain combinations of knee surgeries on both knees at the same time (confirm with trial site).
  • You have had a knee replacement on your other knee that has not fully healed or is not working well.
  • You do not understand the language used in the consent form.
  • Your condition does not meet the requirements or is not suitable for this specific knee implant system, based on the manufacturer's guidelines.
  • You currently have an active infection or blood infection (sepsis), whether treated or untreated.
  • Your body mass index (BMI) is above 40, which is classified as morbidly obese.
  • You are pregnant or breastfeeding at the time of surgery.
  • The study doctor feels your knee condition is too advanced and that a different procedure would suit you better.
  • You are currently taking part in another orthopaedic (bone or joint) clinical trial.
  • You have certain other health conditions that could affect how well the knee replacement works, such as uncontrolled diabetes, serious kidney problems, muscle weakness, poor circulation, or a local active infection (confirm with trial site for the full list).
  • The study doctor feels you have a mental health condition, intellectual disability, or issues with drug or alcohol use that would affect your ability to take part.
  • The study doctor feels you have a nerve or muscle disorder that means you cannot control the knee being treated.
  • You are a prisoner or are considered a vulnerable person under specific international research guidelines.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Julie Lankiewicz, Smith & Nephew, Inc.

Phone: +61 460 727 771

Australian sites

Northern Hospital, Epping,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Smith & Nephew, Inc.
Registry
ClinicalTrials.gov
Start date
12 February 2022
Est. completion
17 April 2026

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China Hong Kong 🇳🇿 New Zealand

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Post-operative Leg Alignment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov