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

NCT ID: NCT02706990

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Physica KR

Patients who have received a Physica KR total knee implant.

Group Type: OTHER

Physica KR

Intervention Type: DEVICE

Kinematic retaining total knee implant

Physica PS

Patients who have received a Physica PS total knee implant.

Group Type: OTHER

Physica PS

Intervention Type: DEVICE

Posterior stabilized total knee implant

Interventions

Physica KR

Kinematic retaining total knee implant

Intervention Type: DEVICE

Physica PS

Posterior stabilized total knee implant

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limacorporate S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Marega, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Camillo, Trento

Locations

Ospedale San Camillo

Trento, Trento, Italy

Countries

Italy

Other Identifiers

K-10

Identifier Type: -

Identifier Source: org_study_id