N/A
Completed N=93
Persona TKA With iASSIST Knee System and iASSIST Knee System
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03227692 ↗
Enrolled (actual)
93
Serious AEs
1.2%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain — 39; 36; 3; 5 Participants
Summary
The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same implant system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Alignment Accuracy of the Knee Femoral Components in Coronal Plain |
39; 36; 3; 5 | — |
| PRIMARY Number of Participants With Alignment Accuracy of the Knee Femoral Components in Sagittal Plain |
36; 24; 6; 17 | — |
| PRIMARY Number of Participants With Alignment Accuracy of the Knee Tibial Components in Coronal Plain |
32; 23; 10; 18 | — |
| PRIMARY Number of Participants With Alignment Accuracy of the Knee Tibial Components in Sagittal Plain |
34; 32; 8; 9 | — |
| SECONDARY Surgery Time |
125.1; 114.2 | — |
| SECONDARY Number of Instrument Trays Used |
5.2; 4.9 | — |
| SECONDARY KSS - Objective Score at 6 Month Postoperatively |
80.8; 77.2 | — |
| SECONDARY KSS-Patient Satisfaction at 6 Month Postoperatively |
24.6; 25.0 | — |
| SECONDARY KSS-function Score at 6 Month Postoperatively |
61.6; 61.5 | — |
| SECONDARY KSS-Patient Expectations at 6 Month Postoperatively |
9.5; 10.1 | — |
| SECONDARY Oxford Knee Score at 6 Month Postoperatively |
36.2; 37.7 | — |
| SECONDARY EQ-5D-3L at 6 Month Postoperatively |
0.8; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria.
- Knee (either unilateral or bilateral) osteoarthritis (varus deformity only)
- Male or female
- At least 20 years of age
- Patients willing to return for follow-up evaluations.
Study Specific Requirements for Principal Investigator/Site
- Principal Investigator (PI) must have experience of at least 5 TKAs of iASSIST Knee with Persona and Persona conventional instrument system before any study specific activities.
- Site has sufficient resources to take limb CT scanning at 6 months follow-up visit.
Exclusion Criteria
Absolute contraindications include:
- Knee degenerative diseases other than knee osteoarthritis (such as necrosis/rheumatoid arthritis)
- Too severe OA deformation (FTA: > 190 degrees/< 175 degrees)
- Active infection (or within 6 weeks after infection)
- Sepsis
- Osteomyelitis
- Any type of implant is inserted in the affected side of lower extremity
- Hip and/or foot disease on the affected side
Additional contraindications include:
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- Diagnosed osteoporosis or osteomalacia
- Metabolic disorders which may impair bone formation
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
Data sourced from ClinicalTrials.gov (NCT03227692). 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.