UnknownNot Applicable

All Ligaments Left In Knee Arthroplasty Trial

United Kingdom260 participantsStarted 2016-09-05

Plain-language summary

Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Primary Osteoarthritis of the knee involving one or more compartments of the joint. * Intact Anterior and Posterior Cruciate Ligaments. * Intact collateral ligaments. * Correctable coronal deformity. * No more than 15 degrees of fixed flexion deformity. Exclusion Criteria: * Age under 18 years. * Revision knee replacement surgery. * Rheumatoid Arthritis. * Traumatic aetiology. * History or clinical signs of ACL rupture. * Previous arthroscopy related to ACL injury or reconstruction. * Correction of a flexion contracture that may require extensive resection of distal femur. * Altered pain perception and / or neurologic affection (for example as a complication arising from diabetes). * Unable to consent for themselves. * Patients with language or cognitive issues that may prevent them completing the follow up requirements. * Contraindications for the device: * Cementless application of components. * BMI ≥40 kg/m2. * Use of Anterior Stabilized Bearings. * Patients with severe pre-operative varus or valgus deformity ≥ 15 degrees. * Correction or revision of previous joint replacement procedure on index knee. * Infection. * Sepsis.Osteomyelitis. * Osteoporosis (requiring treatment). * Relative contraindications include: * Unco-operative patient or patient with neurologic disorders who is incapable of following directions. * Osteoporosis. * Metabolic disorders which may impair bone formation. * Osteomalacia. * Distant foci of inf…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ)

Timeframe: 3 years post randomisation

Trial details

NCT IDNCT03302013

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-04

Contact for this trial

Rachel Dorman

00441865227715 ALLIKAT@ndorms.ox.ac.uk

View on ClinicalTrials.gov More Primary Osteoarthritis of Knee Nos trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.