Orthopilot Elite Post-Market Clinical Follow-Up
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Deformity of Knee
- Degenerative Osteoarthritis
- Instability, Joint
- Posttraumatic Arthropathy
- Rheumatoid Arthritis
- Stiffness of Knee, Not Elsewhere Classified
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be docume...
The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF). The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation >3° from neutral alignment is defined as an outlier.
Tracking Information
- NCT #
- NCT03817632
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon