Clinical trials: sponsored by Istituto Ortopedico Rizzoli
Osteoporosis, Osteopenia
Peripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures
Osteoporosis (OP) is one of most common age-associated and chronic metabolic bone diseases, featured by a decrease of bone mineral density (BMD) that increases the risk of bone fractures.OP guidelines agree that Dual-X-ray…
- Conditions
- Osteoporosis, Osteopenia, Osteoporosis Fracture
- Trial name
- DISCERN (NCT06551155)
- Testing
- Vitality and biological activity of peripheral blood mononuclear cells (PBMCs)
- Where
- 2 sites in Italy
- Volunteers
- 120 people
- Sponsor
- Istituto Ortopedico Rizzoli
Total Hip Arthroplasty (THA)
Observational Study on AI Accuracy in Diagnosing and Treating Failed or Painful Hip Arthroplasty
Primary Goal: This study aims to evaluate the diagnostic and therapeutic accuracy of GPT-4 (an advanced AI language model) compared to three orthopedic surgeons with varying experience levels in cases of failed or painful total…
- Trial name
- PAINGPT (NCT07012577)
- Testing
- GPT-4 Assessment, Arthroplasty Fellow Assessment, Specializing Resident (4th year) Assessment
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Istituto Ortopedico Rizzoli
Degenerative Spine Diseases
Vertebral Bone Marrow Clot for Spinal Surgery
Spinal fusion (SF) is a common orthopedic procedure to treat spinal diseases. Apart from fixation systems, the procedure requires bone grafting to further improve SF.
- Trial name
- NCT05947175
- Testing
- Vertebral bone marrow (vBMA) clot, Bone allograft chips
- Where
- Italy
- Volunteers
- 96 people
- Sponsor
- Istituto Ortopedico Rizzoli
Hemophilia, Sports Physical Therapy
Effectiveness of an Adapted Physical Activity Program for Subjects Suffering From Haemophilia
The present study aims to evaluate the modification of functional capacity induced by an adapted physical activity program in subjects with haemophilia.
- Trial name
- EMO-AFA (NCT06580340)
- Testing
- AFA (Adapted Physical Activity)
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Istituto Ortopedico Rizzoli
Approach-Approach Conflict, Knee Discomfort
Compliance With PROMs Detection Through Digital Support and Correlation Compared Standard to Outpatient Detection in Knee Prosthetics
Two methods for detecting outcomes after knee prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (Oxford Knee Score) VS detection using digital questionnaires…
- Trial name
- DIG-PROMs-k (NCT04752761)
- Testing
- Extrambulatory digital PROMs detection
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Ortopedico Rizzoli
Adolescent Idiopathic Scoliosis
Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis
The aim of the present study is to evaluate the expression of a large panel of microRNAs, already known and validated in other ortopedic pathologies and bone metabolism, in the plasma of Adolescent Idiopathic Scoliosis (AIS)…
- Trial name
- IMIRSA (NCT04746586)
- Testing
- Circulating MiRNA indentification
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Istituto Ortopedico Rizzoli
Osteoarthritis, Knee, Arthropathy of Knee
Total Knee Arthroplasty: Fast Track Protocol is the Future?
Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery.
- Trial name
- FastTrack-G (NCT03869996)
- Testing
- fast track care protocol, standard care protocol
- Where
- Italy
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Istituto Ortopedico Rizzoli
Osteogenesis Imperfecta
Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data
interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta
- Trial name
- 4FRAILTY (NCT06193642)
- Testing
- experimental
- Where
- Italy
- Volunteers
- 33 people
- Sponsor
- Istituto Ortopedico Rizzoli
Vascular Malformations
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study
Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces.
- Trial name
- BESVAM (NCT06189092)
- Testing
- Bleomycin
- Where
- Italy
- Volunteers
- 65 people
- Sponsor
- Istituto Ortopedico Rizzoli
Quality of Life
Compliance With PROMs Detection Through Digital Support and Correlation Compared to Standard Outpatient PROMs Detection in Hip Prosthetics (DIG-PROMs-h)
Two methods for detecting outcomes after hip prosthetic surgery are compared: the traditional one using paper questionnaires administered in the outpatient setting (WOMAC Score) VS detection using digital questionnaires created…
- Trial name
- DIG-PROMs-h (NCT04749511)
- Testing
- Extrambulatory digital PROMs detection
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Istituto Ortopedico Rizzoli
Midline Catheter, Orthopedic Surgery
VADIOR: Advantages of Pre-operative Positioning of Peripherally Inserted Vascular Accesses in DIVA Patients Undergoing Orthopedic Surgery
Our goal is to demonstrate how a standardized approach that involves the pre-operative implantation of the venous access devices in the DIVA patients (EA-DIVA score> or =8), scheduled for orthopedic surgery, impacts both the…
- Trial name
- VADIOR (NCT06904651)
- Testing
- pre-operative positioning of peripherally inserted vascular accesses devices such as midline or minimidline
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- Istituto Ortopedico Rizzoli
Spine Metastasis, Early Goal Directed Therapy
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT.
- Conditions
- Spine Metastasis, Early Goal Directed Therapy, Embolization, Therapeutic, Blood Loss
- Trial name
- Embart (NCT03853434)
- Testing
- Embolization
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Istituto Ortopedico Rizzoli
Osteoporosis
Clinical Validation of BBCT-hip
The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the…
- Trial name
- ValidaBBCT-hip (NCT06270758)
- Testing
- CT scan at the femur
- Where
- 2 sites in Italy
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Istituto Ortopedico Rizzoli
Anterior Shoulder Dislocation, Bone Defects
Clinical and Radiographic Assessment After Surgical Treatment of Anterior Shoulder Dislocation
The purpose of this study is to evaluate the clinical and radiographic results after surgical treatment with implant-free allograft in the treatment of Anterior Shoulder Dislocation and to assess the safety of the surgery.
- Conditions
- Anterior Shoulder Dislocation, Bone Defects, Shoulder Instability
- Trial name
- NCT04520087
- Testing
- allograft fixation
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Istituto Ortopedico Rizzoli
Osteoporotic Fracture of Femur, Osteoarthritis, Hip
Study of Parameters of Osteosarcopenia in Patients With Hip Fracture
The study aims to assess the adequacy of a set of clinical and laboratory investigations for identifying the osteosarcopenia status in patients undergoing a hip replacement for a fragility fracture of the femoral neck.
- Trial name
- NCT04730622
- Testing
- SARC-F questionnaire, Bone tissue histology, Muscle tissue histology
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Istituto Ortopedico Rizzoli
Bicep Tendon Rupture
Evaluation of Clinical and Radiographic Findings in Patients Treated Surgically for Biceps Long Head Injury
This is an interventional, single-center study with clinical and radiographic evaluation, at follow-up of at least 2 years, of patients treated surgically with arthroscopy-assisted distal biceps tendon repair at the Rizzoli…
- Trial name
- Artro-Bic (NCT06483256)
- Testing
- radiographic control
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Istituto Ortopedico Rizzoli
Spinal Fusion
Endothelial Damage in Major Spine Surgery, Measured by Circulating Syndecan-1: an Observational Study.(GlycOrtho)
The goal of this observational study is to learn about endothelial damage in major spine surgery, expressed as rise in circulating Syndecan-1.
- Trial name
- GlycOrtho (NCT06119542)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Istituto Ortopedico Rizzoli
Cruciate Ligament Rupture, Cartilage Injury
The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.
- Trial name
- NCT04184687
- Testing
- Nanofractures, no treatment cartilaginous lesions
- Where
- Italy
- Volunteers
- 4 people
- Sponsor
- Istituto Ortopedico Rizzoli
Degenerative Disc Disease
Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases
Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out…
- Trial name
- NCT06209684
- Testing
- Titanium, Carbofix
- Where
- Italy
- Volunteers
- 118 people
- Sponsor
- Istituto Ortopedico Rizzoli
Hip Arthritis
Retrospective and Prospective Evaluation of Hip Short Stem Performed by Anterior Approach
This study aims to evaluate the clinical, radiographic, and perioperative outcomes of short femoral stems implanted during primary total hip arthroplasty performed through a minimally invasive direct anterior approach (DAA).
- Trial name
- AMISP (NCT07600632)
- Testing
- Total Hip Arthroplasty
- Where
- Italy
- Volunteers
- 400 people
- Sponsor
- Istituto Ortopedico Rizzoli