Establish Implant Accuracy With X-PSI Knee System (X-PSI)

Establish Implant Accuracy With X-PSI Knee System - A Multi-center, Prospective, Non-controlled Post Market Study

The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical alignment and compare them with preoperative planning imaging data. Mechanical alignment in the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared with results reported in the literature using a conventional (non-guided) approach.

Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to mechanical alignment as with conventional instrumentation.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis; Post-traumatic Osteoarthritis
• Intervention / Treatment: Device: X-PSI Knee System

Detailed Description

Patient-specific instruments (PSI) provide surgeons with an anatomically personalized surgery tool. The newly developed and CE-marked X-PSI Knee System is based on long leg x-rays that are used to generate a pre-operative 3D model of the knee. The total knee replacement surgery will be planned according to this 3D model.

The aim of this multi-center, prospective, non-controlled post-market study is to scientifically document the accuracy, cost-effectiveness and subsequent clinical performance of the X-PSI Knee System. The X-PSI pin guides are designed to facilitate a more simplified, efficient and customized TKA procedure compared to conventional, non-guided instrumentation.

To evaluate the accuracy of the X-PSI Knee System, early postoperative (4-6 weeks) imaging data will be analysed with regards to the mechanical alignment (hip-knee-ankle angle) of the leg and matched to preoperative planning imaging data. The X-PSI Knee System cohort will then be compared with current literature (70% of cases within ±3 degrees) where patients were conventionally operated with non-guided surgery. No control group will be studied.

The cost-effectiveness of the X-PSI Knee System will be evaluated with an efficiency matrix to record OR set-up time, surgery time and post-processing time.

Clinical outcome data of the patients will be evaluated 4-6 weeks and 1 year post-surgery with the help of patient questionnaires (VAS pain scale, EQ-5D and Oxford Knee Score), a physical exam and the assessment of radiographs.

The study population will be compromised of males and females requiring total knee arthroplasty and satisfy the inclusion/exclusion criteria. The study will last one (1) year from the time of surgery. The collected data aim to improve the treatment and quality of life of patients suffering from degenerative joint diseases. In addition, shorter surgery times possibly result in reduced risk of infection, decreased time of anaesthesia and better cost-effectiveness.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nienburg, Germany, 31582
    • HELIOS Kliniken Mittelweser GmbH
  • Straubing, Germany, 94315
    • Knie Praxis Prof. Dr. Tibesku
• Netherlands
  • Sittard, Netherlands, 6162
    • Zuyderland Medical Park
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Royal Bournemouth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is 18 years of age or older.
• Patient can follow the X-PSI Knee System imaging protocol as part of standard of care procedures.
• Patient gets TKA treatment which follows the criteria of the appropriate Instruction for Use.
• Patient is willing and able to cooperate in the required postoperative standard of care.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
• Patient has participated in the study-related Informed Consent process and has signed the Ethics Committee approved Informed Consent

Exclusion Criteria:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• Patient meets exclusion criteria of the appropriate Instruction for Use
• Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required from them
• Patient is known to be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Total knee arthroplasty; Patients undergoing total knee arthroplasty	Device: X-PSI Knee System; Patients are operated with X-PSI Knee System guides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Leg Alignment	Achievement of mechanical leg alignment in HKA frontal plane (± 3 degrees) with X-PSI Knee System is as accurate as with standard instrumentation at 4-6 weeks post operation. The X-PSI Knee System cohort will be compared with current literature (70% of cases within ± 3 degrees). No control group will be studied.	4-6 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix	The cost-effectiveness of the X-PSI Knee System will be measured using an efficiency matrix where OR set-up time, surgery time and tray sterilization times will be collected and compared to conventional TKA procedures.	During surgery, immediate pre- and post-surgery processing time

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Clinical Outcome Measure: Visual Analog Score Pain	Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The pain level will be measured using a 10 cm long scale indicating no pain (0) and worst imaginable pain (10).	Baseline, 4-6 weeks and 1 year post-surgery
Patient Clinical Outcome Measure: Oxford Knee Score	The Oxford Knee Score (OKS) is a 12-item patient-reported patient reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). The OKS provides a single summed score which reflects the severity of problems that the respondent has with their knee. Each question (item) is scored from 0 to 4 with 0 being the worst outcome and 4 being the best outcome. The scores are then summed to produce an overall score running from 0 (worst possible) to 48 (best outcome).	Baseline, 4-6 weeks and 1 year post-surgery
Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)	Obtain clincal outcome data on patients treated using the X-PSI Knee System in primary TKA procedures. The EQ-5D VAS is a score to measure general quality of life. The general health state will be assessed on a patient self-reported Visual Analog Scale (VAS) where the endpoints are labelled 0 (worst imaginable health state) to 100 (best imaginable health state). The VAS is used as a quantitative measure of health outcome that reflects the patient's own judgement.	Baseline, 4-6 weeks and 1 year post-surgery
Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System	The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.	Baseline, 4-6 weeks and 1 year post-surgery

Collaborators and Investigators

• Sponsor: Zimmer, GmbH
• Investigators: Study Chair: Oliver Schaetti, PhD, Jr. Clinical Project Lead

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 5, 2018
• Primary Completion (ACTUAL): December 20, 2019
• Study Completion (ACTUAL): November 17, 2020

Study Registration Dates

• First Submitted: August 24, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (ACTUAL): September 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Primary total knee replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CSE2017-01K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No