CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results

Istituto Ortopedico Rizzoli160 enrolled

Overview

The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation. The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay). The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

160

Conditions

Knee Arthroplasty, Total

Interventions

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant * Males and females aged ≥ 45 * Willingness to participate in the study * Acquisition of informed consent to participate Exclusion Criteria: * Patients who are not capable of understanding and willing, and therefore unable to express consent to participation in the study * Patient refusal to participate in the study and to sign the informed consent * Nickel allergy (suspected or diagnosed) * Pregnant women or women of childbearing age who cannot exclude pregnancy

Outcomes

Primary Outcomes

Knee Society Score (KSS)

Knee Society Clinical Rating System (KSS): there are 2 section, "Knee Score" section and a "Functional Score" section; both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions

Time frame: From enrollment to 12 months post-operative followup

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The score measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate worse pain, stiffness, and functional limitations.

Time frame: from enrollment to 12 months post-operative followup

NRS scale

Numeric Pain Rating scale is a unidimensional measure of pain in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 0 = no pain, 10 = worst pain possible

Time frame: from enrollment to 12 months post-operative followup

Secondary Outcomes

surgical time

Time frame: the day of surgical procedure

complications

using Clavien Dindo classification of surgical complications

Time frame: from surgery to 12 month follow-up

delta hemoglobin

For each patient blood loss will be assessed by measuring the difference in hemoglobin (g/dL) on the preoperative blood sample VS last blood sample before discharge

Time frame: from surgery to discharge, up to 4 weeks

Transfusions

It will be accounted the number of blood transfusions that patients may need during the hospital stay until discharge

Time frame: from surgery to discharge, up to 4 weeks

hospital stay

days of hospital stay from surgery to discharge

Time frame: from surgery to discharge, up to 4 weeks

CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts