Clinical trials: Patient Specific Implant
Cardiomyopathies, Gender
Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the…
- Conditions
- Cardiomyopathies, Gender, Implantable Defibrillator User
- Trial name
- BIO-LIBRA (NCT03884608)
- Where
- 49 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Biotronik, Inc.
Osteoarthritis
Multi-Center Study to Evaluate the ConforMIS iUni Knee Implant
Study is prospective and multi-center. Study will include 100 to 200 patients across up to 20 sites.The study sites will be located in the United States.The study objective is to evaluate the safety and performance of the…
- Trial name
- iUni (NCT01117571)
- Testing
- iUni® Unicompartmental Knee Resurfacing Device
- Where
- 8 sites in United States
- Volunteers
- 120 people
- Sponsor
- Restor3D
Temporomandibular Joint Disorders
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
This is a long-term (10 years), retrospective-prospective, observational, single-arm, monocenter study of patients to be treated with the Materialise TMJ Total Arthroplasty System for TMJ replacement.
- Trial name
- NCT06951178
- Testing
- TMJ Total Arthroplasty System (TMJ System)
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Materialise
Degenerative Disc Disease, Osteochondrosis
MySpine MC Versus MySpine Standard
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique.
- Conditions
- Degenerative Disc Disease, Osteochondrosis, Spondylolysis Lumbar
- Trial name
- MC vs STD (NCT05846477)
- Testing
- MySpine
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Medacta International SA
Osteoarthritis
Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
- Trial name
- NCT01861028
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Restor3D
Knee Osteoarthritis
A Prospective Study to Evaluate the iTotal Knee and iPoly XE Tibial Inserts
This study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the iTotal® Cruciate Retaining (CR) Total Knee Replacement System (KRS) who have also had iPoly XE Tibial Inserts…
- Trial name
- NCT03289754
- Testing
- iPoly XE tibial insert with ConforMIS iTotal KRS
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- Restor3D
Degenerative Disc Disease
Cortical Bone Trajectory With Patient Guide
The use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique.
- Trial name
- MySpine MC (NCT05844358)
- Testing
- MySpine MC
- Where
- 2 sites in Belgium
- Volunteers
- 102 people
- Sponsor
- Medacta International SA
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system
- Conditions
- Arthroplasty, Replacement, Shoulder, Glenoid Cavity, Osteoarthritis of the Shoulder
- Trial name
- NCT03806881
- Testing
- reversed glenoid prothesis
- Where
- 4 sites in Belgium, Netherlands
- Volunteers
- 24 people
- Sponsor
- Materialise
Pulmonary Disease, Chronic Obstructive
Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent
The goal of the trial is to establish a method, material, and patient-specific stent design that will last longer, fit better, and cause less trauma to the airway and the patient.
- Trial name
- NCT05050591
- Testing
- Patient-Specific Silicone Airway Stent
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- VisionAir Solutions
E04.525.190, Craniotomy
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Trial name
- NCT01282645
- Testing
- PSI in PEEK
- Where
- 30 sites in Austria, Belgium and 13 more
- Sponsor
- Synthes GmbH