Physica KR Fluoroscopy Study

Total Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655809
• Other study ID #: K-07
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2018

Study information

• Verified date: September 2020
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Radiation:
• Fluoroscopic examination

Locations

Country	Name	City	State
United Kingdom	The Royal Bournemouth Hospital	Bournemouth	Dorset

Sponsors (1)

Lead Sponsor	Collaborator
Limacorporate S.p.a

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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