Trials / Completed
CompletedNCT02934659
Atlas Knee System Clinical System Clinical Study (USA)
Prospective, Multi-Center, Single Arm, Pilot Study to Evaluate Symptom Relief in Subjects With Medial Knee Osteoarthritis Treated With the AtlasTM Knee System for Load Reduction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Moximed · Industry
- Sex
- All
- Age
- 25 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this pilot study is to collect data on the safety and effectiveness of the Atlas Knee System in subjects with medial knee osteoarthritis through 24 months postoperative follow-up.
Detailed description
This study is designed as a prospective, multicenter, open-label, single arm, pilot study. Eligible subjects with symptomatic osteoarthritis of the medial compartment of the knee will be enrolled in the study and will receive the Atlas Knee Implant. The study population will consist of adult subjects age 25 to 80 years, with a diagnosis of medial knee osteoarthritis (Kellgen and Lawrence Grades 1-4, except those with bony erosions) and has pain in the study knee demonstrated as an overall WOMAC pain score of ≥ 40 (scale 0-100).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Atlas(TM) Knee System | The Atlas System is an extra-capsular knee implant designed to unload the medial knee. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2019-07-09
- Completion
- 2023-05-02
- First posted
- 2016-10-17
- Last updated
- 2023-05-09
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02934659. Inclusion in this directory is not an endorsement.