Clinical trial NCT04594447: Physica System KR Vs Physica System CR (K-20)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Replacement
Keywords: Physica KR
Physica CR
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2020-10-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxford Knee Score (OKS)
timeFrame: Baseline to 1 year FU
Secondary outcomes:
measure: 30-second Chair Stand Test (30 CST)
timeFrame: Baseline to 1 year FU
measure: 40 metre fast paced walk test
timeFrame: Baseline to 1 year FU
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline to 1 year FU
measure: Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36
timeFrame: Baseline to 1 year FU
measure: Forgotten Joint Score (FJS)
timeFrame: Baseline to 1 year FU
measure: Range of Motion (ROM)
timeFrame: Baseline to 1 year FU
measure: Knee Society Score (KSS)
timeFrame: Baseline to 1 year FU
measure: Radiographic evaluation
timeFrame: Baseline to 1 year FU
measure: Serious Adverse Event (SAE) incidence
timeFrame: Baseline to 1 year FU
measure: Adverse Event (AE) device related incidence
timeFrame: Baseline to 1 year FU
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
state: Dorset
Study officials:
References: