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NCT03152162 · ClinicalTrials.gov registry record
A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
A clinical trial, sponsored by Restor3D.
- Terminated
- Registry status
- 102
- Enrollment target
NCT03152162: Clinical Trial study, sponsored by Restor3D.
NCT03152162 is a clinical trial that was terminated before completion, run by Restor3D. The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03152162 was terminated before completion, sponsored by Restor3D.
- TERMINATED
- Registry status
- 102 participants
- Enrollment target
Study Summary
This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.
Primary Outcome
Change in Knee Society Scores from the pre-operative visit to the 1-year post-operative visit. The Knee Society Score (KSS) includes an Objective Knee Score, Function Score, Satisfaction Score, and Expectation Score. The objective knee score, completed by the surgeon, includes a VAS score of pain walking on level ground and on stairs or inclines, as well as an assessment of alignment, ligament stability, and ROM, along with deductions for flexion contracture or extensor lag. Patients then record
Interventions
- DEVICE iTotal PS KRS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2022-11-01 |
Why NCT03152162 stopped before completion
NCT03152162 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which iTotal PS KRS is the first listed.
NCT03152162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03152162 about?
NCT03152162 is a clinical study titled "A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System". This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.
What is the current status of trial NCT03152162?
This trial is currently terminated. The enrollment target is 102 participants. The study started on 2017-05-01. Estimated completion is 2022-11-01.
What interventions are being tested in trial NCT03152162?
The interventions under investigation include: iTotal PS KRS (DEVICE).
Who is sponsoring clinical trial NCT03152162?
This trial is sponsored by Restor3D, which has 20 total clinical trials registered on ClinicalTrials.gov.
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