Effectiveness of Inertial Sensors vs the Conventional Technique for the Execution of the Bone Resections in Primary TKA

NCT04242303 | Completed

• 1 other identifier: TKA_EM2
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of surgical technique for the execution of bone resections in total knee arthroplasty. Used technique are: a non-invasive extramedullary technique (EM technique) based on the use of inertial sensors for cutting guides positioning and conventional technique (IM technique), based on the use on intramedullary stem. Our hypothesis is that the EM technique based on the use of inertial sensors leads to a reduction in the number of outliers equal to or greater than 20% compared to the outliers obtained with the conventional technique.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Reduction in the number of cases in which the alignment error on the coronal plane is greater than 3°of error (outlier).

  * HKA alignment on the coronal plane (medial angle between the femoral mechanical axis and the tibial mechanical axis) * coronal femoral angle (medial angle between the femoral mechanical axis and the tangent to the distal condyles of the femoral prosthetic component * tibial coronal angle (medial angle between the tibial mechanical axis and the tangent to the proximal profile of the tibial component) The number of patients with an HKA angle such that 180°-3°\> HKA\> 180°+ 3°or 180°-2°\> HKA\> 180°+ 2°will also be evaluated

  22 months

Secondary Outcomes (4)

• Reduction of the variation in hemoglobin levels during hospitalization.

  22 months

• Reduction of alignment errors of the femoral and tibial resections obtained with the EM technique and with the IM technique on the sagittal plane

  22 months

• Reduction of the period of hospital stay in the EM group compared to the group operated with the standard technique

  22 months

• Inter-operator variability in the EM group

  22 months

Study Arms (2)

EM Technique

EXPERIMENTAL

use of extramedullary technique by means of inertial sensors for the execution of femoral cuts

Procedure: Total knee replacement

IM Technique

ACTIVE COMPARATOR

Use of conventional intramedullary technique for the execution of femoral cuts

Procedure: Total knee replacement

Interventions

Total knee replacement PROCEDURE

Total knee arthroplasty using standard anterior approach. In the EM group, inertial sensor will be used to perform femoral bone cuts. In the IM group, conventional intramedullary nail will be used as reference to perform femoral bone cuts.

EM Technique; IM Technique

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients candidated for total knee arthroplasty
• hip mobility range of at least 30 °
• BMI \<35kg / m2
• Aged between 40 and 80 years

You may not qualify if:

• ipsilateral hip arthrodesis or ankylosis
• non-perforable femoral medullary canal
• °\<HKA \<195 °
• BMI\> 35kg / m2

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Giulio Maria Marcheggiani Muccioli, MD, PhD

  IRCCS Rizzoli Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation of the results obtained will be carried out blindly by an examiner with adequate clinical skills to carry out the evaluation and who does not take part in the operational phases of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be divided into 2 groups, based on the alignment technique used Total number of patients involved: 180 (90 Group A Patients: EM Technique), (90 Group B Patients: IM Technique) Total number of centers involved: 3 Patients per Center: 30 Group A Patients, 30 Group B Patients

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: September 18, 2019
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)