Trials / Withdrawn
WithdrawnNCT06678750
A Prospective Clinical Study Evaluating the Newton™ TKA Protocol
Evaluation of Clinical Outcomes and Patient Recovery in Patients Receiving TKA With Traditional Instrumentation Systems Compared to Full Arc of Motion Gap Balancing Using the Newton™ Knee Protocol: A Prospective Clinical Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Newton-Wellesley Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of clinical outcomes and patient recovery in patients receiving TKA with traditional instrumentation systems compared to full arc of motion gap balancing using the Newton TM Knee Protocol
Detailed description
The purpose of this study is to evaluate patient outcomes, recovery, and patient/surgeon satisfaction of individuals who undergo a total knee arthroplasty (TKA) using mechanical instrumentation (non-navigated) compared to individuals who undergo a TKA with a tibia first gap balancing surgical workflow using the NewtonTM Knee Protocol and navigation-assistance (ExachtechGPS®).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TKA using computer navigation | TKA using Exactech GPS Newton Knee protocol |
| PROCEDURE | TKA | TKA using manual instrumentation |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2024-11-07
- Last updated
- 2025-10-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06678750. Inclusion in this directory is not an endorsement.