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

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706990
• Other study ID #: K-10
• Status: Completed
• Phase: N/A
• First received: March 7, 2016
• Last updated: March 6, 2017
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Limacorporate S.p.a
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Device:
• Physica KR
Kinematic retaining total knee implant
• Physica PS
Posterior stabilized total knee implant

Locations

Country	Name	City	State
Italy	Ospedale San Camillo	Trento

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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