N/A
N=50
In Vivo Kinematics Comparison of Stryker or Zimmer Total Knee Arthroplasty
Knee Prosthesis
Bottom Line
View on ClinicalTrials.gov: NCT01864434 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Kinematics - Deep Knee Bend Activity — -0.43; -1.00; 3.51; -0.42 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA) (Device); Zimmer PCR TKA (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The University of Tennessee, Knoxville
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kinematics - Deep Knee Bend Activity |
-0.43; -1.00; 3.51; -0.42; 5.20; 0.75 | — |
| PRIMARY Kinematics - Ramp up Activity |
-0.31; 0.20; -0.94; -0.61; -0.23; -0.07 | — |
| PRIMARY Kinematics - Ramp Down Activity |
-0.57; -1.11; -1.25; -0.96; 0.83; 0.15 | — |
Summary
This study will compare the kinematics data collected from patients with implants created by different manufacturers to see which of these implants provides a more normal-like kinematic pattern compared to the normal knee.
Eligibility Criteria
Inclusion Criteria
- Must be at least 3 months post-operative with no other surgical procedures conducted within the past 6 months
- Must have body weight of less than 250 lbs
- Must have Body Mass Index of less than 38
- Must be judged clinically successful with a Knee Society Score >90
- Must have 100% post-operative passive flexion with no ligamentous laxity or pain
- Must be able to walk on level ground without aid of any kind
- Must be able to ascend and descend a ramp with a 10 degree incline with no assistance
- Must be willing to sign both Informed Consent and HIPAA forms
- Must be between 160 cm (5'3) and 193 cm (6'4) tall
Exclusion Criteria
- Pregnant or potentially pregnant females
- Unwilling to sign Informed Consent or HIPAA forms
Data sourced from ClinicalTrials.gov (NCT01864434). 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.