# A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

> **NCT03146819** · — · TERMINATED · sponsor: **Restor3D** · enrollment: 31 (actual)

## Conditions studied

- Osteoarthritis, Knee

## Interventions

- **DEVICE:** iTotal PS Knee Replacement System
- **DEVICE:** Off-the-Shelf Knee Replacement System

## Key facts

- **NCT ID:** NCT03146819
- **Lead sponsor:** Restor3D
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2016-12-16
- **Primary completion:** 2017-05-31
- **Final completion:** 2017-05-31
- **Target enrollment:** 31 (ACTUAL)
- **Why stopped:** Unable to identify sufficient number of patients to enroll
- **Last updated:** 2023-10-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03146819

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03146819, "A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf". Retrieved via AI Analytics 2026-06-07 from https://api.ai-analytics.org/clinical/NCT03146819. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
