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Procedure

Surgical Alignments for Knee Arthritis

N/A
Recruiting
Led By Adam Edelstein, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system
Be older than 18 years old
Must not have
Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction
Patients who are not able to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year postoperative
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two ways of performing knee replacement surgery: Mechanical Alignment (MA) and Kinemetic Alignment (KA). MA aims to have the new joint in a neutral position with respect to the thigh

Who is the study for?
This trial is for individuals with knee osteoarthritis needing replacement surgery. It's comparing two surgical methods: traditional Mechanical Alignment (MA) and the newer Kinematic Alignment (KA). Suitable participants should not have conditions that may interfere with the surgery or recovery.
What is being tested?
The study tests whether aligning the new knee joint to mimic natural anatomy (KA) has better outcomes than aligning it in a neutral position (MA). The focus is on patient-rated results, addressing gaps in previous research.
What are the potential side effects?
Potential side effects include pain, swelling, infection risk at the surgical site, blood clots, stiffness, and issues related to anesthesia. KA might reduce soft tissue damage since it avoids extra cuts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having a knee replacement with a specific type of knee system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had knee surgery before, but it wasn't just a scope or ligament repair.
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I am unable to understand or sign the consent form.
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My study knee has had an infection.
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I have been diagnosed with or have a history of chronic pain.
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My joint cannot fully straighten or bend.
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My BMI is over 40.
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I cannot have surgery due to other health issues.
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I have a metabolic bone disease other than mild bone loss.
Select...
I cannot complete questionnaires in English.
Select...
I have been diagnosed with or have a history of inflammatory arthritis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6-week Knee Injury and Osteoarthritis - Joint Replacement Score (KOOS-JR)
Secondary study objectives
Forgotten Joint Score (FJS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Mechanical Alignment (MA)Active Control1 Intervention
Primary TKA with the Medacta SpheriKA, utilizing either MA methodology.
Group II: Kinematic Alignment (KA)Active Control1 Intervention
Primary TKA with the Medacta SpheriKA, utilizing either KA methodology.

Find a Location

Who is running the clinical trial?

Medacta International SAIndustry Sponsor
47 Previous Clinical Trials
8,562 Total Patients Enrolled
21 Trials studying Osteoarthritis
4,241 Patients Enrolled for Osteoarthritis
Northwestern UniversityLead Sponsor
1,647 Previous Clinical Trials
958,557 Total Patients Enrolled
14 Trials studying Osteoarthritis
892 Patients Enrolled for Osteoarthritis
Adam Edelstein, MDPrincipal InvestigatorAssistant Professor of Orthopaedic Surgery
~63 spots leftby Jul 2028
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