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Completed

NCT Number: NCT03201172

Univation® X Follow-Up Study

The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design.

The products under investigation were 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).

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Key information

Conditions

Unicompartmental Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincenz Hospital Brakel

Brakel, 33034, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent UKA in 2015/2016 (using one of the products under investigation)
  • Signed informed consent

Exclusion criteria

  • pregnancy
  • patients < 18 years

Treatment and study plan

Primary Unicompartmental Knee Arthroplasty

Device

Primary implantation of an unicompartmental knee implant

Primary outcomes

  1. Knee joint function

    Time frame: 2 years after primary implantation

    Knee Society Score

Secondary outcomes

  1. KOOS

    Time frame: 2 years after primary implantation

    Knee Injury and Osteoarthritis Outcome Score

  2. axis justice position

    Time frame: preoperative and until discharge from hospital (within 1 week postoperatively)

    radiological analysis

  3. radiolucent lines

    Time frame: 2 years after primary implantation

    radiological analysis

  4. tibial slope

    Time frame: 2 years after primary implantation

    radiological analysis

Other outcomes

  1. Adverse Events

    Time frame: 2 years after primary implantation

    Number of Adverse Events during Follow-Up

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 28, 2017
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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