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Procedure

Bicruciate-retaining vs Posterior-stabilized Knee Replacement for Osteoarthritis

Q: To whom is this clinical trial open?

<p>Up to 77 patients that have <a href="https://www.withpower.com/clinical-trials/knee-pain">knee pain</a>, are aged 18-70, and meet the following requirements can participate in this trial: those who are awaiting a total <a href="https://www.withpower.com/clinical-trials/knee-replacement">knee replacement</a> and are candidates for a bi-cruciate retaining prosthesis, those with disabling bicompartmental gonarthrosis despite conservative treatment attempts, coronal knee malalignment of 10 degrees or less, adequate preoperative range of motion (maximum flexum of 10 degrees and ability to flex greater than 90 degrees), and those with enough intraoperative knee exposure to allow preservation of both cruciate ligaments.</p>

N/A

Waitlist Available

Led By Frédéric Lavoie, MD, M.Sc

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (pre surgery) marx score at 10 yearss after the surgery

Awards & highlights

Study Summary

This trial will compare the clinical and radiological results of patients undergoing total knee replacement surgery according to the type of prosthesis used. It is anticipated that the bicruciate-retaining prosthesis will result in better function of the operated knee than the posterior-stabilized prosthesis.

Who is the study for?

This trial is for people under 70 with severe knee osteoarthritis needing a total knee replacement, who have failed conservative treatments. They must be able to fully extend the knee within 10 degrees and bend it past 90 degrees, have intact cruciate ligaments, less than 10 degrees of knee malalignment, and be capable of undergoing an EOS exam.Check my eligibility

What is being tested?

The study compares two types of total knee replacements: bicruciate-retaining (2C) that keeps both cruciate ligaments versus posterior-stabilized (PS), which does not. It's a randomized controlled trial where patients are assigned by chance using sealed envelopes to determine if one results in better function.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks include pain at the surgery site, infection, blood clots or deep vein thrombosis (DVT), stiffness or difficulty moving the joint as expected after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (pre surgery) marx score at 10 yearss after the surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (pre surgery) marx score at 10 yearss after the surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre surgery) marx score at 10 yearss after the surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in 12-Item Short Form Survey (SF-12) score

Change in EOS imaging pseudo-kinematic - free squatting task - knee abduction and adduction

Change in EOS imaging pseudo-kinematic - free squatting task - knee flexion and extension

+27 more

Other outcome measures

Change in Body Mass Index (BMI)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: bicruciate-retaining total knee arthroplastyExperimental Treatment1 Intervention

The prosthesis is minimally constrained and allows the preservation of both cruciate ligaments. All implants are cemented.

Group II: posterior-stabilized total knee arthroplastyActive Control1 Intervention

The prosthesis requires the excision of both cruciate ligaments

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,560 Total Patients Enrolled

3 Trials studying Osteoarthritis

441 Patients Enrolled for Osteoarthritis

Frédéric Lavoie, MD, M.ScPrincipal InvestigatorCHUM

Media Library

Bicruciate-retaining Total Knee Arthroplasty (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05469776 — N/A

Osteoarthritis Research Study Groups: posterior-stabilized total knee arthroplasty, bicruciate-retaining total knee arthroplasty

Osteoarthritis Clinical Trial 2023: Bicruciate-retaining Total Knee Arthroplasty Highlights & Side Effects. Trial Name: NCT05469776 — N/A

Bicruciate-retaining Total Knee Arthroplasty (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469776 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project restrict volunteers to those over 55 years old?

"According to the inclusion criteria for this particular trial, eligible patients must be aged 18 to 70. However, there are 39 other trials that cater to those under 18 and 727 clinical trials for patients above 65."

Answered by AI

To whom is this clinical trial open?

"Up to 77 patients that have knee pain, are aged 18-70, and meet the following requirements can participate in this trial: those who are awaiting a total knee replacement and are candidates for a bi-cruciate retaining prosthesis, those with disabling bicompartmental gonarthrosis despite conservative treatment attempts, coronal knee malalignment of 10 degrees or less, adequate preoperative range of motion (maximum flexum of 10 degrees and ability to flex greater than 90 degrees), and those with enough intraoperative knee exposure to allow preservation of both cruciate ligaments."

Answered by AI

Are patients being actively recruited for this experiment right now?

"The clinical trial in question is no longer active, based on the information available fromclinicaltrials.gov. This study was first posted on November 1st, 2011 and was last updated on July 19th, 2022. There are 764 other trials currently underway that are actively recruiting patients."

Answered by AI

Recent research and studies

The American Journal of Sports MedicineJournal

Effects of Applied Quadriceps and Hamstrings Muscle Loads on Forces in the Anterior and Posterior Cruciate Ligaments

Markolf, Keith L., Geoffery O'Neill, Steven R. Jackson, and David R. McAllister. 2004. “Effects of Applied Quadriceps and Hamstrings Muscle Loads on Forces in the Anterior and Posterior Cruciate Ligaments”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546503262198.

Clinical Orthopaedics and Related ResearchJournal

In Vivo Kinematics for Subjects with and Without an Anterior Cruciate Ligament

Komistek, Richard D., Jerome Allain, Dylan T. Anderson, Douglas A. Dennis, and Daniel Goutallier. 2002. “In Vivo Kinematics for Subjects with and Without an Anterior Cruciate Ligament”. Clinical Orthopaedics and Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00003086-200211000-00047.

The Journal of ArthroplastyJournal

In Vivo Comparison of Femorotibial Contact Positions for Press-fit Posterior Stabilized and Posterior Cruciate–retaining Total Knee Arthroplasties

Komistek, Richard D., Richard D. Scott, Douglas A. Dennis, David Yasgur, Dylan T. Anderson, and Mary E. Hajner. 2002. “In Vivo Comparison of Femorotibial Contact Positions for Press-fit Posterior Stabilized and Posterior Cruciate–retaining Total Knee Arthroplasties”. The Journal of Arthroplasty. Elsevier BV. doi:10.1054/arth.2002.29329.

Clinical Orthopaedics and Related ResearchJournal