N/A
Completed N=50
Knee Kinematics for Subjects With Zimmer-Biomet Posterior Cruciate Retaining or Posterior Stabilizing Total Knee Arthroplasty
Arthroplasty, Replacement, Knee · Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT04103515 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Lateral Condyle Kinematic Translations - Step up — 1.15; 2.28 mm
Summary
25 subjects implanted with a Zimmer-Biomet Posterior Cruciate Retaining (PCR) total knee arthroplasty (TKA) and 25 subjects implanted with a Zimmer-Biomet Posterior Stabilizing (PS) TKA will be asked to perform stepping up and deep knee bend activities while under fluoroscopic surveillance (x-ray video). The movements between the two different types of TKAs will be compared.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lateral Condyle Kinematic Translations - Step up |
1.15; 2.28 | — |
| PRIMARY Lateral Condyle Kinematics Translations - Deep Knee Bend |
-1.52; -6.80 | — |
| PRIMARY Medial Condyle Kinematics Translations - Step Up |
-0.36; 0.16 | — |
| PRIMARY Medial Condyle Kinematics Translations - Deep Knee Bend |
0.13; -4.25 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will have a Zimmer Persona PCR or PS TKA.
- Subjects must be at least six months post-operative.
- Subjects will have KSS greater than 75.
- Participants must be able to perform the required activities - stepping up and a deep knee bend.
- Subjects must be willing to sign the Informed Consent (IC) / HIPAA form to participate in the study.
- Bilateral subjects may be included in the subject population
Exclusion Criteria
- Pregnant, potentially pregnant or lactating females. To satisfy radiation protocol, each female subject will be asked if she is pregnant, or possibly could be pregnant. A pregnant person will not be allowed to participate in the study. To ensure this, a pregnancy test will be administered to any female participants of child bearing age who have not had a hysterectomy.
- Subjects without the required type of knee implant.
- Subjects who are unable to perform stepping up and deep knee bend.
- Subjects who are unwilling to sign Informed Consent/HIPAA documents.
- Subjects who do not speak English and/or French
Data sourced from ClinicalTrials.gov (NCT04103515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.