Actively Recruiting
Physica TT Tibial Plate Follow up Study
Led by Limacorporate S.p.a · Updated on 2026-01-22
130
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications.
CONDITIONS
Official 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 a total knee replacement (TKR) and suitable for receiving Physica Porous KR or Physica Porous PS femoral component in combination with Physica TT Tibial Plate.
- Age 18 years or older.
- Candidate for primary total knee replacement based on clinical indications including non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, or other medical reasons deemed appropriate by the investigator.
- Well-preserved and functioning collateral ligaments with either absent or non-functioning posterior cruciate ligament and severe knee instability (for Physica Porous PS) or undamaged and functional posterior cruciate ligament (for Physica Porous KR).
- Able to understand the study conditions, comply with rehabilitation, and willing to attend all follow-up visits.
- Signed informed consent approved by the ethics committee before study activities.
You will not qualify if you...
- Severe knee instability due to lack of collateral ligament integrity or function; important joint instability and deficiency of posterior cruciate ligament for Physica Porous KR.
- Any active or suspected infection or previous infection affecting the prosthetic joint.
- Previous partial knee replacement, patellectomy, or high tibial osteotomy.
- Significant bone loss on femoral or tibial joint side.
- Malignant cancer with life expectancy less than 2 years or treatments affecting postoperative course.
- Known allergy or incompatibility to implant materials or metal hypersensitivity.
- Septicaemia.
- Persistent acute or chronic osteomyelitis.
- Open epiphyses (immature bone growth).
- Necrotic bone.
- Severe arterial vascular insufficiency or nerve diseases in lower limbs interfering with evaluation.
- Compromised bone stock unable to support implant fixation.
- Systemic or metabolic disorders causing progressive bone deterioration.
- Any disease or dependency affecting implant performance.
- Major pathology or medical intervention affecting study evaluation.
- Neurological or musculoskeletal disorders affecting gait or recovery.
- Neuromuscular or neurosensory deficits hampering device assessment.
- Psychiatric illness preventing understanding of study details.
- Participation in other surgical or pain management studies affecting outcomes.
- Female patients who are pregnant, nursing, or planning pregnancy.
- Important osteoporosis or haemophilic disease.
- Internistic problems posing high risk for surgery.
AI-Screening
AI-Powered Screening
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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
CONTACT
F
Francesca Citossi
CONTACT
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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