Fluoroscopic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design

In Vivo Kinematic Analysis of Total Knee Replacement With a Kinematic Retaining or a Posterior Stabilized Design During Activities of Daily Living

The aim of this study is to evaluate the in vivo kinematics of TKA performed with two different prosthesis: a kinematic retaining (Physica KR) and a posterior-stabilized (Physica PS) design by means of fluoroscopic analysis during activities of daily living (rising from a chair, stairs climbing, leg extension). In comparison with asymptomatic knee. Patterns of femoral rollback will be analyzed to assess if they are motor-task dependent and correlated with clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Device: Physica KR; Device: Physica PS

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Trento, Italy, 38122
    • Ospedale San Camillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients submitted to Total knee arthroplasty (TKA) with Physica KR or PS;
2. Patients with an appropriate initial fixation and stability of the knee prosthesis;
3. Patients achieving a minimum flexion of 100° or a Knee Society Score (KSS) ≥ 65 (fair/good postoperative outcome) at 6-month follow-up;
4. Patients affected by primary or secondary Osteoarthritis (OA) before surgery;
5. Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
6. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.

Exclusion Criteria:

1. Patients with misalignment or axial malrotation of the knee prosthesis;
2. Patients not able to achieve a minimum flexion of 100° or with a KSS Knee Score ≤ 65 points at 6-month follow-up;
3. Patients who had or have planned a surgery on their uninvolved knee within a year;
4. Muscular insufficiency or absence of muscololigamentous supporting structures required for adequate soft tissue balance;
5. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
6. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
7. Any psychiatric illness that would prevent comprehension of the details and nature of the study;
8. Participation in any experimental drug/device study within the 6 months prior to the screening visit
9. Female patients who are pregnant, nursing, or planning a pregnancy due to x-rays exposition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Physica KR; Patients who have received a Physica KR total knee implant.	Device: Physica KR; Kinematic retaining total knee implant
Other: Physica PS; Patients who have received a Physica PS total knee implant.	Device: Physica PS; Posterior stabilized total knee implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the roll-back mechanism measured with the tibio-femoral contact points at different degrees of flexion	Using a software to replicate the movement using Computer-aided design (CAD) models. The movement is studied and the distance made by the femur on the tibia is calculated giving the information of the roll back.	6 months

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a
• Investigators: Principal Investigator: Luca Marega, MD, Ospedale San Camillo, Trento

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2017
• Last Update Submitted That Met QC Criteria: March 6, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: K-10