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

NCT02706990 | Completed

• 1 other identifier: K-10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Physica KR

OTHER

Patients who have received a Physica KR total knee implant.

Device: Physica KR

Physica PS

OTHER

Patients who have received a Physica PS total knee implant.

Device: Physica PS

Interventions

Physica KR DEVICE

Kinematic retaining total knee implant

Physica KR

Physica PS DEVICE

Posterior stabilized total knee implant

Physica PS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Limacorporate S.p.a: lead

Study Sites (1)

Ospedale San Camillo

Trento, Trento, 38122, Italy

Location

Study Officials

• Luca Marega, MD

  Ospedale San Camillo, Trento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 11, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 7, 2017

Record last verified: 2016-09

Locations

IT (1)