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

Not Applicable

Not yet recruiting

• Conditions: Clinical Outcomes; 3D Knee Kinematics; Knee Instability; Knee Osteoarthritis; Precision of Surgical Actions
• Interventions: Device: Computer Guidance of Surgical Actions; Device: Repeated Measurements of Knee Alignment and Kinematics

• Registration Number: NCT01674816
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer Guidance of Surgical Actions	Computer Guidance of Surgical Actions	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.
Repeated Measurements of Knee Alignment and Kinematics	Repeated Measurements of Knee Alignment and Kinematics	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.

Primary Outcome Measures

Name	Time	Method
3D knee kinematic assessment	1 day	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)
Precision of guided surgical actions	On post-operative imaging (six weeks after surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Clinical results	At each post-operative visit (six weeks, six months, one year, and two years after surgery)	The clinical results after surgery will be assessed through angular and linear measurements using 3D imaging.

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada