Kinematics Analysis of SIGMA® Partial Knee System (NCT02949336) | Clinical Trial Compass
CompletedNot Applicable
Kinematics Analysis of SIGMA® Partial Knee System
Switzerland18 participantsStarted 2016-12-19
Plain-language summary
The proposed study is a prospective collection of health related personal data (observational study). A total of approximately 10 subjects with traditional medial SIGMA® High Performance Partial Knee System and 10 ACL deficient subjects with medial SIGMA® High Performance Partial Knee System are analyzed during sitting onto a chair and getting up, deep knee bend, stance and swing phase of level walking, downhill walking (ramp descent) and stair descent at least 12 months post-operatively, in terms of 3D fluoroscopic assessed tibio-femoral motion as well as simultaneous skin marker assessed whole leg motion and ground reaction forces. All the video-fluoroscopic testing is performed at the Institute for Biomechanics at the ETH Zurich. The UKA subjects are recruited based on the inclusion and exclusion criteria.
The primary objective is to quantify and describe the three-dimensional kinematics for patients with a traditional medial SIGMA® High Performance Partial Knee System (functional ACL and tibial posterior slope matching the native bone) during these daily activities.
The secondary objective is to evaluate patients with the same medial UKA implant (SIGMA® High Performance Partial Knee System) in an ACL deficient knee, where the UKA was implanted at a 50% reduced tibial posterior slope relative to the native knee.
Who can participate
Age range
18 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 (group 1):
* medial SIGMA® High Performance Partial Knee System due to medial OA
* Intact/functional ACL
* BMI ≤ 32
* good clinical outcome, KOOS \>70
* no or very low pain VAS \< 2
* Follow-up at least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group
* Age ≥ 18 years
Exclusion criteria (group 1):
* Actual significant problem on lower extremities
* Misaligned UKA
* Deficient / non-functional ACL (Lachman Test)
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing the motion tasks
* Pregnancy
Inclusion criteria (group 2):
* medial SIGMA® High Performance Partial Knee System due to medial OA
* Deficient / non-functional ACL
* Central to posterior wear of medial tibial plateau (pre-op MRI)
* 50% reduced tibial posterior slope after UKA (post-op radiograph)
* BMI ≤ 32
* good clinical outcome, KOOS \>70
* no or very low pain VAS \< 2
* Follow-up at least one year post-op
* Standardized general health survey score (SF-12) within the normal range for people in their age group
* Age ≥ 18 years
Exclusion criteria (group 2):
* Actual significant problem on lower extremities
* Misaligned UKA / non-reduced posterior tibial slope (post-op radiograph)
* Intact / functional ACL
* Any other arthroplasty at the lower extremities
* Patient incapable to understand and sign informed consent
* Incapable of performing t…
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.