Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant (UNI_XF_PRO)

Aesculap

Status: Not yet enrolling

Conditions: Degenerative Disease; Gonarthritis

Treatments: Device: univation® XF Pro

Study type: Observational

Funder types: Industry

Identifiers

NCT06657248

AAG-O-H-22003

Details and patient eligibility

About

The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.

Full description

The product under investigation is used in routine clinical practice and according to the authorized Instructions for Use (IfU). The data that is obtained in routine clinical use will be documented in an electronical Case Report Form (eCRF). The study's main purpose is the collection of clinical data on the safety and performance of the redesigned univation® XF Pro implant.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for a primary medial unicompartmental knee endoprosthesis

Acc. to Instructions for Use:

• Both cruciate ligaments intact
• Lateral ligaments intact
• Leg axis amenable to passive correction
• Varus deformity under 15°
• Bending capability of at least 90°
• Extension deficit no greater than 5-10°
• Written informed consent of patient
• Kellgran & Lawrence Score > II (only straight or varus
• Patients with moderate radiological symptoms
• Patients without clinical symptoms

Exclusion criteria

• Pregnancy
• Patient age <18 and > 75 years
• BMI ≥ 40
• High risk patients ASA > III

Trial design

150 participants in 1 patient group

univation® XF Pro

Description:

Primary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro

Treatment:

Device: univation® XF Pro