Clinical trial NCT03275246: Establish Implant Accuracy With X-PSI Knee System
Official title: Establish Implant Accuracy With X-PSI Knee System - A Multi-center, Prospective, Non-controlled Post Market Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Osteoarthritis
Post-traumatic Osteoarthritis
Keywords: Primary total knee replacement
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-09-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mechanical Leg Alignment
timeFrame: 4-6 weeks post-surgery
Secondary outcomes:
measure: Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix
timeFrame: During surgery, immediate pre- and post-surgery processing time
Other outcomes:
measure: Patient Clinical Outcome Measure: Visual Analog Score Pain
timeFrame: Baseline, 4-6 weeks and 1 year post-surgery
measure: Patient Clinical Outcome Measure: Oxford Knee Score
timeFrame: Baseline, 4-6 weeks and 1 year post-surgery
measure: Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)
timeFrame: Baseline, 4-6 weeks and 1 year post-surgery
measure: Patient Clinical Outcome Measure: EQ-5D-3L Descriptive System
timeFrame: Baseline, 4-6 weeks and 1 year post-surgery
Locations:
city: Nienburg
country: Germany
facility: HELIOS Kliniken Mittelweser GmbH
city: Straubing
country: Germany
facility: Knie Praxis Prof. Dr. Tibesku
city: Sittard
country: Netherlands
facility: Zuyderland Medical Park
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
Study officials:
affiliation: Jr. Clinical Project Lead
name: Oliver Schaetti, PhD
role: STUDY_CHAIR
References: