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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2031-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gonarthritis Degenerative Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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univation® XF Pro

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

univation® XF Pro

Intervention Type DEVICE

Primary medial unicompartmental knee arthroplasty

Interventions

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univation® XF Pro

Primary medial unicompartmental knee arthroplasty

Intervention Type DEVICE

Other Intervention Names

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Unicompartmental knee arthroplasty

Eligibility Criteria

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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