Physica System KR vs Physica System CR (K-20)

Total Knee Replacement Clinical Trial

Official title:

A Post-market,Monocentric,Randomised,Open-label,Parallel Group,Prospective Clinical Study Evaluating the Functional Outcome of the Kinematic Physica KR Total Knee Replacement System vs the Standard Physica CR Total Knee Replacement System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04594447
• Other study ID #: K-20
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2021
• Source: Limacorporate S.p.a
• Contact: Fabiana Pavan
• Phone: +390432945357
• Email: fabiana.pavan[@]limacorporate.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-market, monocentric, randomised, open-label, parallel group, prospective study conducted in patients who have to perform a total knee replacement (TKR) with Physica KR or Physica CR system.

Description:

The aim of the study is to evaluate the clinical, radiographic and PROMs outcomes of Total Knee Arthroplasty (TKA) with 2 Lima TKR design: Physica KR and Physica CR (randomization 1:1) from preoperative to 1-year follow-up.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and females of any race requiring a total knee replacement and suitable for the use of one of the two configurations of the Physica system.

2. Age = 18 years old,

3. Patients who are suffering from non-inflammatory degenerative joint disease (NIDJD):

including knee osteoarthritis, post-traumatic knee arthritis, avascular necrosis; or patient who are suffering from inflammatory joint disease including rheumatoid arthritis.

4. Suitable candidates for TKR who have undamaged and functional collateral ligaments

5. Suitable candidates for TKR with Physica KR and CR who have an undamaged and functional posterior cruciate ligament.

6. Patients who understand the conditions of the study and are willing and able to comply with the prescribed rehabilitation and to perform all scheduled follow-up visits.

7. Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery.

Exclusion Criteria:

1. Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.

2. Patients with active or any suspected infection (on the affected knee or systemic)

3. Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy

4. Patients with significant bone loss on femoral or tibial joint side

5. Current treatment for malignant and/or life-threatening nonmalignant disorders

6. Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials

7. Patient with open epiphyses (immature patient with active bone growth).

8. Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation

9. Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis

10. Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant

11. Any concomitant disease and dependence that might affect the performance of the implanted prosthesis

12. Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation (e.g. primary osteoporosis with significant bone loss, haemophilic disease, septicaemia, persistent acute or chronic osteomyelitis)

13. Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation

14. Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device

15. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint

16. Any psychiatric illness that would prevent comprehension of the details and nature of the study

17. Patients currently participating in any other surgical intervention studies or pain management studies

18. Female patients who are pregnant, nursing, or planning a pregnancy.

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Device:
• Physica Kinematic Retaining knee replacement
modular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation
• Physica Cruciate Retaining knee replacement
modular knee prosthesis with posterior cruciate ligament (PCL) preservation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Limacorporate S.p.a	NAMSA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Knee Score (OKS)	Changes of the Oxford Knee Score (OKS) from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.; Specifically designed and developed to assess function and pain after TKR surgery. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.	Baseline to 1 year FU
Secondary	30-second Chair Stand Test (30 CST)	Functional changes in 30-second Chair Stand Test (30 CST) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.	Baseline to 1 year FU
Secondary	40 metre fast paced walk test	Functional changes in 40 metre fast paced walk test from preoperative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.	Baseline to 1 year FU
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)	Changes in the Knee injury and Osteoarthritis Outcome Score (KOOS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.; KOOS is a 42-item self-administered self-explanatory questionnaire that covers five patient-relevant dimensions: Pain, Other Disease-Specific Symptoms, Active Daily Living Function, Sport and Recreation Function, and knee-related Quality of Life. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems	Baseline to 1 year FU
Secondary	Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36	Changes in 36-Item Short Form Health Survey (SF-36) outcome from pre-operative (baseline) to 1 year after the implant.; This questionnaire includes 8 scales of differing domains of health: physical functioning, bodily pain, role-physical, general health, vitality, role emotional, social functioning, and mental health. Each scale is scored on a 0 to 100 scale with a 100 representing the best score possible.	Baseline to 1 year FU
Secondary	Forgotten Joint Score (FJS)	Changes in the Forgotten Joint Score (FJS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.; It comprises measures for the assessment of joint-specific patient-reported outcome and focus on patients' awareness of a specific joint in everyday life. It consists of 12 questions and is scored using a 5-point Likert response format (never-almost never-seldom- sometimes-mostly) with the raw scores transformed onto a 0-100 point scale. High scores indicate good outcome.	Baseline to 1 year FU
Secondary	Range of Motion (ROM)	Changes in the Range of Motion (ROM) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.	Baseline to 1 year FU
Secondary	Knee Society Score (KSS)	Changes in the Knee Society Score (KSS) from pre-operative (baseline) to 1 year after the implant of the Physica KR compared to Physica CR designs.; KSS is divided into two components to assess the knee clinically through the physical examination, and to assess the individual's functionality . The maximum score of 100 points that is the best outcome.	Baseline to 1 year FU
Secondary	Radiographic evaluation	Radiographic implant evaluation and stability assessment of the Physica KR compared to Physica CR designs at baseline and 1 year after the implant.	Baseline to 1 year FU
Secondary	Serious Adverse Event (SAE) incidence	Changes Incidence, type and severity of all device-related Serious Adverse Events (SAEs) at intra-operatively, at discharge, 6 months and 1 year after the implant.	Baseline to 1 year FU
Secondary	Adverse Event (AE) device related incidence	Incidence, type and severity of all device-related Adverse Events (AEs) at intraoperatively, at discharge, 6 months and 1 year after the implant	Baseline to 1 year FU