Orthopilot Elite Post-Market Clinical Follow-Up

Aesculap

Status: Completed

Conditions: Deformity of Knee; Stiffness of Knee, Not Elsewhere Classified; Degenerative Osteoarthritis; Posttraumatic Arthropathy; Instability, Joint; Rheumatoid Arthritis

Treatments: Device: Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0; Device: Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1

Study type: Observational

Funder types: Industry

Identifiers

NCT03817632

AAG-O-H-1708

Details and patient eligibility

About

Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty

Full 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 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.

Enrollment: 217 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion: Inclusion Criteria:

• Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
• Dated and signed informed consent

Exclusion: Exclusion Criteria

• Pregnancy
• Patients < 18 years
• Patients unable to participate at the follow-up examination (physically, mentally)
• Previous joint replacement at the indexed knee

Trial design

217 participants in 2 patient groups

A Standard

Description:

Computer assisted primary total knee replacement with OrthoPilot FS 101 navigation system and Software 5.1

Treatment:

Device: Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1

B Elite

Description:

Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0

Treatment:

Device: Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0