Univation® X Follow-Up Study

Unicompartmental Knee Arthroplasty Clinical Trial

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®.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201172
• Other study ID #: AAG-O-H-1641
• Status: Completed
• Start date: September 25, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2021
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 1, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Unicompartmental Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
Germany	St. Vincenz Hospital Brakel	Brakel

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Number of Adverse Events during Follow-Up	2 years after primary implantation
Primary	Knee joint function	Knee Society Score	2 years after primary implantation
Secondary	KOOS	Knee Injury and Osteoarthritis Outcome Score	2 years after primary implantation
Secondary	axis justice position	radiological analysis	preoperative and until discharge from hospital (within 1 week postoperatively)
Secondary	radiolucent lines	radiological analysis	2 years after primary implantation
Secondary	tibial slope	radiological analysis	2 years after primary implantation