Fluoroscopic Analysis of Total Knee Replacement With a Ki... | NCT02706990

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

NCT02706990

Sponsor

Limacorporate S.p.a

Status

Completed

Last Update Posted

Mar 7, 2017Actual

Enrollment

34Actual

Phase

Not Applicable

Conditions

Total Knee Replacement

Interventions

Physica KR
Physica PS

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Mar 7, 2016

First Submission Date that Met QC Criteria

Mar 7, 2016

First Posted Date

Mar 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2017

Last Update Posted Date

Mar 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Physica KR	Device	Kinematic retaining total knee implant	Physica KR

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided