Establish Implant Accuracy With X-PSI Knee System

NCT03275246 | Terminated Results

• 1 other identifier: CSE2017-01K
• Study Type: interventional
• Target: 8
• Locations: 3 countries
• Sites: 4

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.

Conditions

Knee Osteoarthritis; Post-traumatic Osteoarthritis

Keywords

Primary total knee replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cost-effectiveness of the X-PSI Knee System Using an Efficiency Matrix

  During surgery, immediate pre- and post-surgery processing time

Other Outcomes (4)

• Patient Clinical Outcome Measure: Visual Analog Score Pain

  Baseline, 4-6 weeks and 1 year post-surgery

• Patient Clinical Outcome Measure: Oxford Knee Score

  Baseline, 4-6 weeks and 1 year post-surgery

• Patient Clinical Outcome Measure: EQ-5D Visual Analogue Scale (VAS)

  Baseline, 4-6 weeks and 1 year post-surgery

Study Arms (1)

Total knee arthroplasty

EXPERIMENTAL

Patients undergoing total knee arthroplasty

Device: X-PSI Knee System

Interventions

X-PSI Knee System DEVICE

Patients are operated with X-PSI Knee System guides

Total knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is unwilling or unable to give consent or to comply with the follow-up program.
• 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

Sponsors & Collaborators

• Zimmer, GmbH: lead

Study Sites (4)

HELIOS Kliniken Mittelweser GmbH

Nienburg, 31582, Germany

Location

Knie Praxis Prof. Dr. Tibesku

Straubing, 94315, Germany

Location

Zuyderland Medical Park

Sittard, 6162, Netherlands

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The study was prematurely terminated due to slow enrloment. Only 3 subjects were operated with X-PSI. Out of the 3 subjects, 2 reached the final 1 year follow-up. Due to the very low number of subjects, no statistical analysis was conducted on the data.

Results Point of Contact

• Title: Oliver Schaetti
• Organization: Zimmer Biomet

oliver.schaetti@zimmerbiomet.com

0041588548901

Study Officials

• Oliver Schaetti, PhD

  Jr. Clinical Project Lead

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: September 7, 2017
• Study Start: October 5, 2018
• Primary Completion: December 20, 2019
• Study Completion: November 17, 2020
• Last Updated: October 6, 2021
• Results First Posted: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); NL (1); GB (1)