Univation XM France

Osteoarthritis, Knee Clinical Trial

Official title:

A Prospective, Observational, Monocentre 5-year Follow-up Clinical Trial on a Historical Consecutive Cohort of Unicompartmental Knee Arthroplasty Patients Treated With the Mobile Bearing Unicondylar Knee Prosthesis Univation XM

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04199481
• Other study ID #: AAG-O-H-1822
• Status: Withdrawn
• Start date: August 2020
• Est. completion date: August 2023

Study information

• Verified date: July 2020
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is set up due to regulatory purposes and to collect routine clinical data of the mobile-bearing implant univation XM. The study is designed as a prospective follow-up study with a historic patient cohort who have been treated with the product under investigation two years ago. This design is selected to quicker realize follow-up data as patients have already been treated in the past.

As the mobile version of the implant is not widely used, the study will be set up as a monocentric study in France. The clinical hypothesis of the study is that patients who are treated with the product under investigation have a similar outcome and survival rate in comparison to other established unicondylar knee systems on the market. Comparison for the later evaluation will be taken out of recent orthopaedic registries.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient has received a primary mobile bearing UKA at the study site between January 2017 and December 2018 using the product under investigation

• Patient's written consent and willingness to participate at the clinical study and the follow-up examinations

Exclusion Criteria:

• Pregnancy

• Patient Age <18 years at the time of the surgery

Related Conditions & MeSH terms

• Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthrosis of Knee
• Unicompartmental Knee Arthroplasty

Locations

Country	Name	City	State
France	CHU Hopital Hautepierre	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B. Braun Medical S.A.S. France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate of the Implant	Revision-free survival rate after 5 years according to Kaplan-Meier	5 years after surgery
Secondary	Development of Knee joint function	Postoperative Development of knee joint function measured with the Knee Society Score (KSS). The KSS is composed of two subgroups "Knee Score" and "Function Score"; both parts have a maximum score of 100, where higher values represent better results.	in the postoperative course, up to 5 years after surgery
Secondary	Development of Oxford Knee Score	A patient-reported outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total knee replacement (TKR) arthroplasty. Oxford Knee Score has a maximum of 48 points indicating satisfactory knee function	in the postoperative course, up to 5 years after surgery
Secondary	Intraoperative/surgery Data	Surgical and intraoperative data collected will include the date and duration of the surgery, selected implants and sizes, blood loss and implant descriptions. Surgical duration is to be measured from the time of incision to the time of skin closure, skin-to-skin. All potential Adverse Events will be collected during the surgical procedure and/or from the surgical record and will be documented on the intra-operative Evaluation Form.	intraoperative
Secondary	Radiographic evaluation	The outcome and function of a knee prosthesis is influenced by the postoperative alignment of the leg and the orientation in reference to the axis. Incorrect positioning can lead to an increased implant wear and functional limitations; The aim of a postoperative alignment within 3° varus to 3° valgus will be assessed using long leg x-rays up to 5 years after surgery	in the postoperative course, up to 5 years after surgery
Secondary	Rate of Serious Adverse Events	As part of the follow-up examination, any upcoming (serious) adverse device events or effects related or not related to the product under investigation, will be documented in the dedicated Case Report Forms. Recorded complications will be categorized and analyzed in order to assess the safety of the univation XM prosthesis	in the postoperative course, up to 5 years after surgery