Minimally Invasive Three-dimensional Knee Kinematic Assessment and Surgical Guidance Using Ultrasonic Rigid Registration

NCT01674816 | Not Yet Recruiting DMC

• 1 other identifier: CE12.006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Problem: Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee. Hypothesis: A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting. Objectives :

• Demonstrating the capacity of the system to precisely measure 3D knee kinematics
• Quantifying the reproducibility of the kinematic measurements
• Measuring the impact of knee surgical procedures on knee kinematics
• Assessing the correlations between measured articular kinematics and clinical results after knee surgery
• Integrating the novel measuring system to the surgical flow of three knee surgical procedures
• Quantifying the precision and reproducibility of the surgical actions guided by the system
• Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique

Conditions

Knee Osteoarthritis; Knee Instability; 3D Knee Kinematics; Precision of Surgical Actions; Clinical Outcomes

Outcome Measures

Primary Outcomes (3)

• 3D knee kinematic assessment

  The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)

  1 day

• Precision of guided surgical actions

  The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.

  During surgery

• Precision of guided surgical actions

  The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.

  On post-operative imaging (six weeks after surgery)

Secondary Outcomes (6)

• Clinical results

  At each post-operative visit (six weeks, six months, one year, and two years after surgery)

• Clinical results

  At each post-operative visit (six weeks, six months, one year, and two years after surgery)

• Clinical results

  At each post-operative visit (six weeks, six months, one year, and two years after surgery)

• Clinical results

  At each post-operative visit (six weeks, six months, one year, and two years after surgery)

• Clinical results

  At each post-operative visit (six weeks, six months, one year, and two years after surgery)

Study Arms (2)

Repeated Measurements of Knee Alignment and Kinematics

ACTIVE COMPARATOR

Patients in the Repeated Measurements Arm will have the kinematic measurement protocol repeated twice before and twice after the surgical procedure; the procedure itself will be performed with the traditional technique, i.e without guidance by the system.

Device: Repeated Measurements of Knee Alignment and Kinematics

Computer Guidance of Surgical Actions

ACTIVE COMPARATOR

Patients in the Computer Guidance of Surgical Actions Arm will have the kinematic measurement protocol performed only once before and once after the surgical procedure; the procedure itself will be performed with guidance by the system.

Device: Computer Guidance of Surgical Actions

Interventions

Repeated Measurements of Knee Alignment and Kinematics DEVICE

Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.

Repeated Measurements of Knee Alignment and Kinematics

Computer Guidance of Surgical Actions DEVICE

Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.

Computer Guidance of Surgical Actions

Eligibility Criteria

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

You may qualify if:

• Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))

You may not qualify if:

• Active infection
• Atypical morphology and/or alignment of the lower limbs
• Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
• Knee flexion contracture of 10 degrees or more
• Knee flexion of less than 120 degrees

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Eiffel Medtech: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Frédéric Lavoie, MD, MSc, FRCSC

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Lavoie, MD MSc FRCSC

CONTACT

1-514-890-8000; fredericlavoiemd@gmail.com

Fidaa Al-Shakfa, MSc

CONTACT

1-514-890-8000; f.alshakfa.crchum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 29, 2012
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CA (1)