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Univation® X Follow-Up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201172
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Aesculap AG

Brief Summary:

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).


Condition or disease Intervention/treatment
Unicompartmental Knee Arthroplasty Device: Primary Unicompartmental Knee Arthroplasty

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
Univation® X Device: Primary Unicompartmental Knee Arthroplasty
Primary implantation of an unicompartmental knee implant

iUni® Device: Primary Unicompartmental Knee Arthroplasty
Primary implantation of an unicompartmental knee implant




Primary Outcome Measures :
  1. Knee joint function [ Time Frame: 2 years after primary implantation ]
    Knee Society Score


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Adverse Events [ Time Frame: 2 years after primary implantation ]
    Number of Adverse Events during Follow-Up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201172


Locations
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Germany
St. Vincenz Hospital Brakel
Brakel, Germany, 33034
Sponsors and Collaborators
Aesculap AG
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT03201172    
Other Study ID Numbers: AAG-O-H-1641
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No