Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
Overview
- Phase
- Not Applicable
- Intervention
- univation® XF Pro
- Conditions
- Not specified
- Sponsor
- Aesculap AG
- Enrollment
- 150
- Locations
- 8
- Primary Endpoint
- Functional patient-reported outcome
- Status
- Not yet recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.
Detailed Description
The product under investigation is used in routine clinical practice and according to the authorized Instructions for Use (IfU). The data that is obtained in routine clinical use will be documented in an electronical Case Report Form (eCRF). The study's main purpose is the collection of clinical data on the safety and performance of the redesigned univation® XF Pro implant.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Indication for a primary medial unicompartmental knee endoprosthesis
- •Acc. to Instructions for Use:
- •Both cruciate ligaments intact
- •Lateral ligaments intact
- •Leg axis amenable to passive correction
- •Varus deformity under 15°
- •Bending capability of at least 90°
- •Extension deficit no greater than 5-10°
- •Written informed consent of patient
- •Kellgran \& Lawrence Score \> II (only straight or varus
Exclusion Criteria
- •Pregnancy
- •Patient age \<18 and \> 75 years
- •High risk patients ASA \> III
Arms & Interventions
univation® XF Pro
Primary medial unicompartmental knee arthroplasty treated with implantation of unicompartmental knee prosthesis univation® XF Pro
Intervention: univation® XF Pro
Outcomes
Primary Outcomes
Functional patient-reported outcome
Time Frame: 5 years post-op
The Oxford Knee Score (OKS) is a reliable 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing total knee replacement. It is short, reproducible, valid and sensitive to clinically important changes over time. Each of the 12 questions on the OKS is scored in the same way with the score decreasing as the reported symptoms increase (i.e. become worse). All questions are laid out with response categories denoting least (or no) symptoms to the left of the page (scoring 4) and those representing greatest severity lying on the right hand side (scoring 0), as detailed for question 1 below. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome.
Secondary Outcomes
- Implant survival [Kaplan-Meier](until 5 years postoperatively)
- Quality of Life [EQ-5D-5L] compared to baseline(Preoperatively (baseline) and 3 months, 1 year, 2 years, 5 years postoperatively)
- Progress of Clinical Outcome [Forgotten Joint Score-12] over follow-up period(3 months, 1 year, 2 years, 5 years postoperatively)
- Radiological assessment: axis alignment (long leg x-ray) over time(at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively)
- Radiological assessment: comparison of tibial slope over time(at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively)
- Radiological assessment: Patella x-ray(at discharge (approx. 7-10 days postoperatively), 3 months, 1 year, 2 years, 5 years postoperatively)
- Number of Adverse events / serious adverse events over time(During the course of the study up to 5 years postoperatively)
- Number of Participants with radiological complications over time(During the course of the study up to 5 years postoperatively)