Univation® X Follow-Up Study

NCT ID: NCT03201172

Last Updated: 2021-04-15

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

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-25

Study Completion Date

2020-04-01

Brief Summary

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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).

Detailed Description

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Conditions

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Unicompartmental Knee Arthroplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Univation® X

Primary Unicompartmental Knee Arthroplasty

Intervention Type DEVICE

Primary implantation of an unicompartmental knee implant

iUni®

Primary Unicompartmental Knee Arthroplasty

Intervention Type DEVICE

Primary implantation of an unicompartmental knee implant

Interventions

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Primary Unicompartmental Knee Arthroplasty

Primary implantation of an unicompartmental knee implant

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Vincenz Hospital Brakel

Brakel, , Germany

Site Status

Countries

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Germany

References

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Haaker R, Moussa A, Sabev D. No advantage for patient-specific UKA in comparison with standard UKA regarding clinical and functional results at short-term follow-up. Eur J Orthop Surg Traumatol. 2025 Aug 27;35(1):362. doi: 10.1007/s00590-025-04467-2.

Reference Type DERIVED
PMID: 40866508 (View on PubMed)

Other Identifiers

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AAG-O-H-1641

Identifier Type: -

Identifier Source: org_study_id

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