Evaluation of the Clinical Outcomes of the Total Knee ps Prosthesis Implanted With the Use of Inertial Sensors

Recruiting

• Conditions: Prosthesis Durability
• Interventions: Device: Knee arthroplasty

• Registration Number: NCT06321042
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

evaluate the clinical outcome of the implantation of a specific primary TKA model implanted with the aid of inertial sensors for the execution of bone cuts through the administration of questionnaires for the calculation of clinical-functional scores;

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-13
• Study First Submitted: 2024-01-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-01
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male and female subjects 50 years of age or older and less than 85 years of age (>50 and <85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes:

   • to. Primary or secondary osteoarthritis
   • b. Collagen disorders and/or avascular necrosis of femoral condyle
   • c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture <10°) -

2. Patients consent and able to complete scheduled study procedures and follow-up assessments.

3. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.

Exclusion Criteria

• Simultaneous participation in other studies
• Patients not capable of understanding and wanting and therefore unable to sign the informed consent
• Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient treated with PS Link Symphoknee prosthesis and Orthokey perseus alignment device	Knee arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Knee injury and Osteoarthritis Outcome Score	24 months	The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). the score goes from 0 to 100
Knee Society Score	24 months	Two sections, one evaluating the patient's function and one for his clinical conditions, overall score goes from 0 to 100
Forgotten joint score	24 months	a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint
Western Ontario and McMaster Universities Arthritis Index	24 months	The test evaluates main aspects of arthritis such as pain, stiffness articulation and functionality. The score goes from 0 to 96
36-Item Short Form Health Survey	24 months	is a valid and reliable tool for measuring health outcomes in patients with musculoskeletal pain, but its sensitivity to clinical changes in patients with specific disorders may be limited, rated on a scale of 0 to 100, with 0 and 100 being minimum and maximum possible scores.

Secondary Outcome Measures

Name	Time	Method
Radiographic evaluation of prosthetic femoral component positioning	5 days after index surgery	measurement of prosthetic femoral component alignment according to femoral mechanical axis

Trial Locations

Locations (1)

Stefano Zaffagnini; 🇮🇹 Bologna, Italia, Italy