Actively Recruiting
Post Market Clinical Study of Total Knee Arthroplasty Outcomes Using Physica Porous KR or PS Femoral Components with Physica TT Tibial Plate in Cementless Configuration
Led by Limacorporate S.p.a · Updated on 2026-01-22
130
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical, radiographic, and patient-reported outcomes of total knee replacement surgery using the Physica TT Tibial Plate combined with either the Physica Porous KR or Physica Porous PS femoral components. The study aims to assess how well these devices perform up to two years after surgery, including the short-term survival of the implant and the occurrence of early complications. This observational study focuses on patients needing total knee replacements due to various joint diseases or injuries. The study involves two groups of participants who have undergone total knee arthroplasty with either the Physica TT Tibial Plate combined with the Physica Porous KR femoral component or the Physica TT Tibial Plate combined with the Physica Porous PS femoral component. The devices are used in a cementless configuration during surgery. Data will be collected from the time of surgery and monitored over a two-year period to evaluate the outcomes. Participants will be followed for up to two years after their surgery, during which researchers will assess knee function, pain, joint movement, and implant stability through clinical evaluations and radiographic imaging. Patient-reported outcomes such as the Knee Society Score, Oxford Knee Score, Forgotten Joint Score, and pain scales will be measured over time. The study will also monitor any adverse effects related to the devices. Follow-up visits and assessments will occur regularly throughout the two-year period to gather comprehensive data on the implant's performance and participant recovery.
CONDITIONS
Brief Title
Physica TT Tibial Plate Follow up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of any race requiring total knee replacement and suitable for Physica Porous KR or PS femoral component with Physica TT Tibial Plate
- Age 18 years or older
- Candidate for primary total knee replacement due to non-inflammatory or inflammatory degenerative joint diseases or other medical reasons as determined by investigator
- Well-preserved and functioning collateral ligaments
- For Physica Porous PS: absent or non-functioning posterior cruciate ligament with severe knee instability
- For Physica Porous KR: undamaged and functional posterior cruciate ligament
- Ability to understand study conditions, comply with rehabilitation, and attend all follow-up visits
- Signed informed consent approved by ethics committee
You will not qualify if you...
- Severe knee joint instability due to lack of collateral ligament integrity or deficient posterior cruciate ligament (for Physica Porous KR)
- Active or suspected infection or history of infection affecting prosthetic joint
- Previous partial knee replacement, patellectomy, or high tibial osteotomy
- Significant bone loss on femoral or tibial side
- Malignant cancer with life expectancy less than 2 years or affecting postoperative course
- Allergy or hypersensitivity to implant materials
- Septicaemia or osteomyelitis
- Open epiphyses (active bone growth)
- Necrotic bone
- Severe arterial vascular insufficiency or nerve disease affecting evaluation
- Compromised bone stock unable to support implant
- Progressive bone deterioration from systemic/metabolic disorders
- Other diseases or dependencies affecting implant performance
- Major clinical pathology or medical interventions affecting study evaluation
- Neurological or musculoskeletal disorders affecting gait or recovery
- Neuromuscular or neurosensory deficits affecting device assessment
- Psychiatric illness preventing study comprehension
- Participation in other surgical or pain management studies affecting outcomes
- Pregnancy, nursing, or planning pregnancy
- Significant osteoporosis or haemophilic disease
- Serious internal medical problems posing high surgical risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years after surgery
Participants who underwent total knee arthroplasty with the Physica TT Tibial Plate and Physica Porous KR or PS femoral components are observed.
Multiple visits over 2 years for assessments
Duration - Up to 2 years after surgery
Participants are monitored to assess implant performance, range of motion, pain levels, and potential adverse device effects over time.
Regular follow-up visits up to 2 years post-surgery
Trial Site Locations
Total: 3 locations
1
Casa di Cura San Camillo Hopital
Forte dei Marmi, Lucca, Italy, 55042
Actively Recruiting
2
Casa di Cura Carmona
Messina, Italy, 98100
Actively Recruiting
3
Istituto Clinico Porta Sole
Perugia, Italy, 06100
Actively Recruiting
Research Team
D
Domizia Baldassi
F
Francesca Citossi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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