Osteoarthritis Trial, Recruiting (NCT03895489)

Osteoarthritis Trial, Recruiting NCT03895489 Sponsor: University of Alberta Condition: Osteoarthritis

Printed from Voxsanity (voxsanity.com.au) — NCT03895489 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Osteoarthritis

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 have signed an approved consent form agreeing to take part in the study.
You are a man or a woman who is not pregnant, and you are between 50 and 75 years old at the time the device is implanted.
You have been diagnosed with a non-inflammatory degenerative joint disease (a type of joint wear-and-tear condition, such as osteoarthritis — confirm with trial site).
You are scheduled to have your first total knee replacement surgery using a posterior-stabilized implant (a specific type of knee replacement — confirm with trial site).
You are willing and able to attend follow-up appointments, have X-rays taken as required, and take part in rehabilitation after surgery.

Who may not be able to join:

Your Body Mass Index (BMI) is 40 or higher (confirm with trial site if you are unsure of your BMI).
Your knee has a significant angular deformity greater than 15 degrees, a bend that cannot fully straighten by more than 20 degrees, or a bending range of motion of less than 90 degrees in either leg.
You have an active or suspected hidden infection in or around the knee joint that needs to be treated.
You have had any orthopaedic (bone or joint) surgery on your legs in the past 6 months, or you are expected to need any such surgery (other than this knee replacement) within the next year.
You need both knees replaced at the same time, or you have had a partial or full knee replacement on the other knee within the past 6 months.
You have other health conditions that could make it difficult to properly assess how safe or effective the device is (confirm with trial site).
You need a revision surgery to fix or replace a previously implanted knee replacement, or you have had a knee fusion on the affected joint.
You have a known allergy or sensitivity to the materials used in the device.

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 15 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

Phone: 780-492-6713

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT03895489

Sponsor: University of Alberta

Phase: Not Applicable

Status: Recruiting

Condition: Osteoarthritis

Trial contact: 780-492-6713

More information: https://clinicaltrials.gov/study/NCT03895489

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have signed an approved consent form agreeing to take part in the study.
You are a man or a woman who is not pregnant, and you are between 50 and 75 years old at the time the device is implanted.
You have been diagnosed with a non-inflammatory degenerative joint disease (a type of joint wear-and-tear condition, such as osteoarthritis — confirm with trial site).
You are scheduled to have your first total knee replacement surgery using a posterior-stabilized implant (a specific type of knee replacement — confirm with trial site).
You are willing and able to attend follow-up appointments, have X-rays taken as required, and take part in rehabilitation after surgery.

Who may not be able to join:

Your Body Mass Index (BMI) is 40 or higher (confirm with trial site if you are unsure of your BMI).
Your knee has a significant angular deformity greater than 15 degrees, a bend that cannot fully straighten by more than 20 degrees, or a bending range of motion of less than 90 degrees in either leg.
You have an active or suspected hidden infection in or around the knee joint that needs to be treated.
You have had any orthopaedic (bone or joint) surgery on your legs in the past 6 months, or you are expected to need any such surgery (other than this knee replacement) within the next year.
You need both knees replaced at the same time, or you have had a partial or full knee replacement on the other knee within the past 6 months.
You have other health conditions that could make it difficult to properly assess how safe or effective the device is (confirm with trial site).
You need a revision surgery to fix or replace a previously implanted knee replacement, or you have had a knee fusion on the affected joint.
You have a known allergy or sensitivity to the materials used in the device.

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 15 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Alberta

Registry

ClinicalTrials.gov

Start date

9 September 2019

Est. completion

3 April 2025

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

knee flexion-extension range of motion (ROM) during level treadmill walking; knee flexion-extension range of motion (ROM) during level treadmill walking; knee abduction-adduction range of motion (ROM) during level treadmill walking; knee abduction-adduction range of motion (ROM) during level treadmill walking; Max velocity of knee flexion-extension during level treadmill walking; Max velocity of knee flexion-extension during level treadmill walking; Max velocity of knee abduction-adduction during level treadmill walking; Max velocity of knee abduction-adduction during level treadmill walking;...

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: 15 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