N/A
Completed N=130
Orthosensor vs Conventional Total Knee Arthroplasty
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT03628378 ↗
Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component — 46; 43; 45; 46 score on a scale
Summary
In a randomized-controlled fashion, this investigation will evaluate the use of the Verasense technology to achieve optimal TKA balance. Patients will be randomized to either: 1) undergo manual soft tissue balancing or 2) soft tissue balancing with the Verasense. The primary outcomes of interest will include patient-reported outcomes as well knee range of motion at 3 months, 6 months, 1 year, and 2 years. Secondary outcomes of interest will include pain level as assessed by the visual analogue scale (VAS) in the acute post-operative and follow up periods, ambulation distance during inpatient physical therapy postoperatively, surgical time, tourniquet time, amount of opioid consumption, length of hospital stay, incidence of arthrofibrosis and subsequent manipulation under anesthesia. The investigators hypothesize that the use of the Verasense technology will lead to improved soft tissue balancing in TKA and ultimately result in favorable patient-reported outcomes and postoperative knee range of motion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Score on the 12-Item Short Form Survey (SF-12) - Physical Component |
46; 43; 45; 46; 49; 47 | — |
| PRIMARY Average Score on the 12-Item Short Form Survey (SF-12) - Mental Component |
48; 48; 46; 45; 43; 43 | — |
| PRIMARY Average Score on the WOMAC Functional (F) Limitation Subscale |
22; 28; 21; 22; 13; 16 | — |
| PRIMARY Average Score on the WOMAC Stiffness (S) Subscale |
35; 37; 31; 30; 18; 20 | — |
| PRIMARY Average Score on the WOMAC Pain (P) Subscale |
18; 25; 16; 16; 12; 12 | — |
| PRIMARY Knee Society Functional Score (KSFS) |
68; 55; 65; 68; 77; 71 | — |
| PRIMARY Average Arc of Range of Motion (Extension to Flexion) |
116; 113; 117; 119; 117; 116 | — |
| SECONDARY Visual Analogue Scale Pain Level |
3.2; 3.2 | — |
| SECONDARY Ambulation (Distance) |
351; 361 | — |
Eligibility Criteria
Inclusion Criteria
- Primary total knee replacement
Exclusion Criteria
- Revision knee surgery
- Prior knee surgery
Data sourced from ClinicalTrials.gov (NCT03628378). 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.