Physica KR Fluoroscopy Study

NCT ID: NCT02655809

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-11-30

Brief 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).

Conditions

Total Knee Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• 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

Fluoroscopic examination

Intervention Type: RADIATION

Interventions

Fluoroscopic examination

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limacorporate S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Countries

United Kingdom

Other Identifiers

K-07

Identifier Type: -

Identifier Source: org_study_id