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Not Applicable
Cemented vs. Cementless Partial Knee Replacement for Knee Arthroplasty
N/A
Waitlist Available
Research Sponsored by Anderson Orthopaedic Research Institute
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 2 years postoperative
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness of two types of partial knee replacements; one that uses a 3-D printed metal component and another that uses cement.
Who is the study for?
This trial is for people aged 18-85 who need a medial fixed bearing partial knee replacement and are suitable for both cemented and cementless fixation. It excludes non-English speakers, those with very weak bones, prior high tibial osteotomy with hardware, unsuitable bone quality or cuts during surgery, smokers, or if they need total knee arthroplasty due to advanced arthritis.
What is being tested?
The study compares two types of partial knee replacements: one using a new modular 3-D printed porous metal that doesn't use cement (cementless), and the other using traditional methods where the components are secured with cement (cemented). The goal is to see if there's any difference in clinical outcomes after at least two years.
What are the potential side effects?
While specific side effects aren't listed here, generally speaking, potential side effects from knee replacement surgeries can include pain at the site of surgery, swelling, infection risk around the implant area and possible issues related to how well the implant fixes to the bone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years postoperative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Knee Society Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CementlessExperimental Treatment1 Intervention
Cementless fixation partial knee replacement
Group II: CementedActive Control1 Intervention
Cemented fixation partial knee replacement
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Who is running the clinical trial?
Anderson Orthopaedic Research InstituteLead Sponsor
13 Previous Clinical Trials
1,520 Total Patients Enrolled
Robert HopperStudy ChairAnderson Orthopaedic Research Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My bones are suitable for surgery with or without bone cement.I have had a partial knee replacement with a fixed bearing.I am between 18 and 85 years old.I need a total knee replacement due to severe arthritis.I had surgery on my upper shinbone and hardware was used.
Research Study Groups:
This trial has the following groups:- Group 1: Cemented
- Group 2: Cementless
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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