Active — Not RecruitingNot Applicable

Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?

Sweden70 participantsStarted 2014-03-03

Plain-language summary

The goal of this randomized study is to see if using patient-specific instruments (PSI) during total knee replacement surgery improves outcomes compared to standard instruments. The study focuses on adults with knee osteoarthritis who need knee replacement surgery. Specifically, it aims to answer the following questions: Does using PSI improve knee function and stability as experienced by the patient? Does PSI lead to more normal knee motion during bending and straightening? Does PSI result in at least as good tibial (shin bone) component fixation as standard instruments? Is PSI more cost-effective than standard instruments? Researchers will compare PSI with standard instruments in 70 patients. Half will receive knee replacement surgery using PSI, and the other half with standard instruments. Patients will be randomly assigned to each group. Participants will: Undergo knee replacement surgery with either PSI or standard instruments. Have a series of follow-ups, including assessments of knee function, satisfaction, and alignment of the knee implant, conducted before surgery and at 3 months, 1 year, 2 years, and 5 years after surgery. The study will include patients aged 40-75 with primary osteoarthritis, a body mass index (BMI) below 35, and no other major medical conditions that could impact surgery. Patients will also need to be willing to undergo necessary imaging, such as magnetic resonance imageing (MRI) scans and standing X-rays. Outcomes will be measured using various assessment tools, including the Oxford Knee Score, Knee Society Score, and a patient satisfaction survey. Researchers will also record surgery details, such as operating time, blood loss, and knee implant size. Imaging methods, including MRI, computed tomgraphy (CT) scans, and specialized X-rays, will be used to evaluate knee alignment and stability over time. The results of this study are expected to provide insights into whether patient-specific instruments offer clinical or economic advantages over traditional tools in knee replacement surgery.

Who can participate

Age range

40 Years – 75 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: * Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4 * Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees * Age 40-75 years * BMI \<35 * American Society of Anesthesiologists (ASA) score 1-3. * Coming from independent living in own home * Able and willing to undergo MRI scan (for custom patients), full-leg standing radiographs and follow up with RSA * Written informed consent. Exclusion Criteria: * Cortisone treatment during the last 6 months before operation * Neurological diseases with symptoms, stroke with sequel * Endocrine diseases with symptoms * OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities * BMI \>=35 * OA of the hip with symptoms * Ongoing infection * Any metal within 150 mm from the joint line on the side to become operated * Unable or unwilling to participate in the follow-up.

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 (OKS)

Timeframe: Prior to and 2 years post surgery

Trial details

NCT IDNCT06720012

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery trials