Trials / Recruiting
RecruitingNCT04728542
ORIGIN® vs. VANGUARD® PS Observational Study
A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 140 (estimated)
- Sponsor
- Symbios Orthopedie SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty.
Detailed description
This is a prospective, comparative, randomized, double arm, monocentric, observational, post-market study with 140 subjects with 2 years follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ORIGIN PS System | 70 surgeries with the ORIGIN PS System |
| DEVICE | VANGUARD PS System | 70 surgeries with the VANGUARD System |
Timeline
- Start date
- 2021-03-25
- Primary completion
- 2025-02-01
- Completion
- 2027-02-01
- First posted
- 2021-01-28
- Last updated
- 2024-10-04
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04728542. Inclusion in this directory is not an endorsement.