Physica KR Fluoroscopy Study

Physica KR: In Vivo Kinematic Analysis of a Novel Total Knee Replacement Implant

The aim of this study is to assess the in vivo kinematics and range of motion of a single-surgeon clinical series of TKA performed with a fixed-bearing cruciate retaining total knee arthroplasty that has a roll-back mechanism and compare it with the kinematic of the normal healthy knee.

Patients would be evaluated by fluoroscopic examination during weight bearing activities (lounging, kneeling and stairs climbing).

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Radiation: Fluoroscopic examination

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Bournemouth, Dorset, United Kingdom, BH7 7DW
      • The Royal Bournemouth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patientsoperated in The Royal Bournemouth Hospital NHS Foundation Trust and who has received a Physica KR implant
2. Patients achieving a ROM ≥ 100° at 6 week follow-up in the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
3. Patients affected by primary or secondary OA before surgery;
4. Patients with an appropriate intial fixation and stability of the knee prosthesis;
5. Patients with undamaged and functional collateral and posterior cruciate ligaments (no ligamentous imbalance or pain);
6. Patients who understand the requirements of the study and are willing and able to comply with activities required for fluoroscopic examination;
7. Patients who have signed the Ethics Committee approved study-specific Informed Consent Form.

Exclusion Criteria:

1. Patients with a ROM < 100° at 6-week follow-up in Physica KR clinical trial (K-06- Study protocol 30/10/2013 v 1.0);
2. Patients affected by rheumatoid arthritis;
3. Patients with malalignment or axial malrotation of the knee prosthesis;
4. Patients who had or have planned a surgery on their uninvolved knee within a year;
5. Muscular insufficiency or absence of muscoligamentous supporting structures required for adequate soft tissue balance;
6. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation;
7. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device;
8. Any psychiatric illness that would prevent comprehension of the details and nature of the study;
9. Participation in any experimental drug/device study within the 6 months prior to the preoperative visit, excluding the Physica KR clinical trial (K-06 Study protocol 30/10/2013 v 1.0);
10. Female patients who are pregnant, nursing, or planning a pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Physica KR; Patients who have received a Physica KR total knee implant.	Radiation: Fluoroscopic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the roll-back mechanism by measuring the contact point between tibia and femur components in millimeters	Using a software to replicate the movement using 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 after surgery

Collaborators and Investigators

• Sponsor: Limacorporate S.p.a

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: K-07