No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 79
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
95 (estimated)
Sponsor
Northwestern University · Other
Who this trial is looking for
This trial is looking for patients who need knee replacement surgery. Participants will help compare two different ways of doing the surgery to see which is better for different patients.
Are You a Good Fit for This Trial?
Rules you outInflammatory arthritisKnee infectionChronic painChronic opioid useMetabolic musculoskeletal disorders
You may be able to join if
I am planning to have a primary knee replacement surgery.
I can read and understand the consent form and follow-up questions.
You may not be able to join if
I have misalignment of my knee greater than 15 degrees.
I have a knee flexion problem greater than 15 degrees or less than 90 degrees.
My body mass index (BMI) is over 40.
I have had a knee surgery before, except for minor procedures.
I have a history of inflammatory arthritis or an infection in my knee.
I have chronic pain or use opioids regularly.
I am receiving workers' compensation for my knee condition.
I cannot complete questionnaires in English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the kn…
Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee. More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee. This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case.
Some studies have found no difference in outcomes between MA and KA, whereas others have found KA to be superior. But these were small studies or studies that did not consider patient-rated outcomes.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system
* Able to read and understand consent form and PRO instruments and willing to return for follow up visits
Exclusion Criteria:
* Varus or Valgus malalignment \>15 degrees to mechanical axis
* Flexi…
Inclusion Criteria:
* Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system
* Able to read and understand consent form and PRO instruments and willing to return for follow up visits
Exclusion Criteria:
* Varus or Valgus malalignment \>15 degrees to mechanical axis
* Flexion contracture \>15 degrees or flexion \<90 degrees
* BMI \>40
* Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction
* Diagnosis or history of any of the following
* inflammatory arthritis
* infection in study knee
* chronic pain
* chronic opioid use
* metabolic musculoskeletal disorder other than osteopenia/osteoporosis
* Patients receiving workers' compensation for study condition
* Patients who cannot complete questionnaires in English
* Patients with comorbidities preventing surgery
* Patients who are not able to provide informed consent
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.