Trials / Terminated
TerminatedNCT03023410
Using Intraoperative Sensing Technology to Evaluate Revision Total Knee Arthroplasty
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 1 (actual)
- Sponsor
- Orthosensor, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will attempt to draw relationships between the soft-tissue related complications contributing to early TKA revision and the loading and positional patterns from intraoperative tibial trial sensors. The data from the sensors may enable the surgeon to address such soft-tissue abnormalities that may otherwise be unknown during traditional total knee revision procedures. The utilization of sensors should in theory, help diagnose the potential causes attributing to soft-tissue imbalance and may lead to a decreased need for an all component revision. Furthermore, the economic implications from converting a total revision to a partial revision could have a profound effect to the patient and healthcare provider such as decreased rehabilitation regimes and opportunity for cost savings. Eligible revision patients who agree to participate will be followed for a period of 12 months following the revision procedure. Patient reported outcomes measures (PROM) such as the 2011 Knee Society Score (KSS) and the Veterans Rand 12-Item Health Survey (VR-12) will be collected at baseline (pre-operatively) and at 6 weeks, 6 months and 12 months post-procedure. All outcomes will be scored to observe changes from baseline at 12-months. Cost-analyses of sensor-assisted revision TKA will be performed to include OR costs, facility and physician fees, as well as payments to post-acute collaborators such as SNFs, rehab hospitals, PT and home care providers. A quantitative analysis of commercial payer claims / usage data (e.g., CMS Medpar data) will be used to examine costs associated with traditional revision TKA procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | VERASENSE | Sensor-Assisted Revision TKA |
Timeline
- Start date
- 2018-01-17
- Primary completion
- 2018-07-16
- Completion
- 2018-07-16
- First posted
- 2017-01-18
- Last updated
- 2025-01-29
- Results posted
- 2025-01-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03023410. Inclusion in this directory is not an endorsement.