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

NCT04594447 | Terminated

• 1 other identifier: K-20
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

Physica KR; Physica CR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 30-second Chair Stand Test (30 CST)

  Baseline to 1 year FU

• 40 metre fast paced walk test

  Baseline to 1 year FU

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  Baseline to 1 year FU

• Medical Outcomes Survey Short Form-36 (SF-36) RAND SF-36

  Baseline to 1 year FU

• Forgotten Joint Score (FJS)

  Baseline to 1 year FU

Study Arms (2)

Physica KR

OTHER

Subject that receive Physica Kinematic Retaining total Knee replacement system

Device: Physica Kinematic Retaining knee replacement

Physica CR

OTHER

Subject that receive Physica Cruciate Retaining total Knee replacement system

Device: Physica Cruciate Retaining knee replacement

Interventions

Physica Kinematic Retaining knee replacement DEVICE

modular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation

Physica KR

Physica Cruciate Retaining knee replacement DEVICE

modular knee prosthesis with posterior cruciate ligament (PCL) preservation

Physica CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥ 18 years old,
• 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.
• Suitable candidates for TKR who have undamaged and functional collateral ligaments
• Suitable candidates for TKR with Physica KR and CR who have an undamaged and functional posterior cruciate ligament.
• 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.
• Patients who have signed the Ethics Committee/IRB approved study-specific Informed Consent Form prior to the surgery.

You may not qualify if:

• Patients with severe instability of the knee joint secondary to the absence of collateral ligament integrity and/or function.
• Patients with active or any suspected infection (on the affected knee or systemic)
• Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy
• Patients with significant bone loss on femoral or tibial joint side
• Current treatment for malignant and/or life-threatening nonmalignant disorders
• Patients with known incompatibility or allergy to the product materials, and/or metal hypersensitivity to implant materials
• Patient with open epiphyses (immature patient with active bone growth).
• Vascular insufficiency of lower limbs severe enough to interfere with the study evaluation
• Patients with bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis
• Patients with systemic or metabolic disorders leading to progressive bone deterioration which may impair fixation and stability of the implant
• Any concomitant disease and dependence that might affect the performance of the implanted prosthesis
• 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)
• Patients who have significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery and evaluation
• Patients who have neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint

Sponsors & Collaborators

• Limacorporate S.p.a: lead
• NAMSA: collaborator

Study Sites (1)

The Royal Bournemouth Hospital

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: September 30, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)