Clinical trials: Proximal Femur Fracture
Fractures
Feasibility And Safety Study Of rhBMP-2/CPM For Hip Fractures
The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.
- Trial name
- NCT00384358
- Testing
- rhBMP-2/CPM, surgical intervention alone
- Where
- 30 sites in United States, Australia and 8 more
- Volunteers
- 108 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hip Fractures, Subtrochanteric Fractures
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body.
- Conditions
- Hip Fractures, Subtrochanteric Fractures, Intertrochanteric Fractures, Pertrochanteric Fracture
- Trial name
- Chimaera (NCT05197335)
- Testing
- Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws
- Where
- 8 sites in Italy
- Volunteers
- 206 people
- Sponsor
- Orthofix s.r.l.
Osteoporosis
RECONFIRM - Study of AGN1 LOEP in Patients with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study.
- Trial name
- NCT05202678
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- AgNovos Healthcare, LLC
Osteoporosis
GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study.
- Trial name
- NCT05966974
- Where
- Belgium
- Volunteers
- 44 people
- Sponsor
- AgNovos Healthcare, LLC
Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck
N-Force Screws Augmented With N-Force Blue in Hip Fractures
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
- Conditions
- Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- Trial name
- N-Force (NCT03807349)
- Testing
- N-Force Screws Augmented with N-Force Blue
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Zimmer Biomet
Femoral Fractures
Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before…
- Trial name
- NCT01599221
- Testing
- EBA2
- Where
- 3 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Citieffe S.r.l
Primary and Secondary Bone Tumor in the Proximal Femur Region
Clinical Evaluation of Moment Tumor Hip Replacement Products
The aim is to ensure that the patients are functionally adequately and painlessly mobilized with the proximal femoral tumor resection prosthesis used, to increase the survival of patients who underwent wide resection, and to…
- Trial name
- KRIOS (NCT05847868)
- Testing
- Moment Tumour Hip Prothesis
- Where
- 7 sites in Turkey (Türkiye)
- Volunteers
- 42 people
- Sponsor
- Estas Tıbbi Mamülleri Medikal
Osteoporosis
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study.
- Trial name
- NCT07594639
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 305 people
- Sponsor
- AgNovos Healthcare, LLC
Fracture of Hip, Osteoporosis
Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side
HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal…
- Trial name
- NCT03648775
- Testing
- Y-STRUT® (Hyprevention, Pessac, France)
- Where
- 5 sites in France
- Volunteers
- 10 people
- Sponsor
- Hyprevention
Peripheral Vascular Diseases
ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
- Trial name
- NCT00180505
- Testing
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Where
- 13 sites in Austria, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- Abbott Medical Devices
Osteopenic Women, Proximal Femur Fracture
Copley II: Long-term Outcome Follow-up Study of Osteoporotic Women Who Underwent a Local Osteo-Enhancement Procedure (LOEP) in the Proximal Femur
To evaluate longer-term (5-7 years) outcomes of the twelve (12) subjects treated with AGN1 Femoral LOEP in the clinical study "A Prospective Pilot Evaluation of Percutaneous Osteo-supplementation in the Proximal Femur of…
- Trial name
- NCT06799143
- Volunteers
- 12 people
- Sponsor
- AgNovos Healthcare, LLC
Proximal or Diaphyseal Humerus Fracture, Diaphyseal or Distal Femur Fracture
Observational Patient Registry of the Dynamic Locking Screws
The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS.
- Conditions
- Proximal or Diaphyseal Humerus Fracture, Diaphyseal or Distal Femur Fracture, Diaphyseal, Distal or Proximal Tibia Fracture
- Trial name
- DLS (NCT02656628)
- Testing
- Dynamic Locking Screw 3.7mm and 5.0mm
- Where
- Australia
- Sponsor
- Synthes GmbH
Pathological Fracture of Hip, Bone Metastases
Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.
- Trial name
- NCT03579212
- Testing
- Y-STRUT® (Hyprevention, Pessac, France)
- Where
- 4 sites in France
- Volunteers
- 16 people
- Sponsor
- Hyprevention
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Femoral Fracture (Proximal)
DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial
The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.
- Trial name
- ATN (NCT00546429)
- Testing
- Intramedullary nailing
- Where
- 4 sites in United States
- Volunteers
- 62 people
- Sponsor
- DePuy Orthopaedics
Proximal (Subtrochanteric)Femoral Fractures, Distal Femoral Fractures
Evaluation of the Safety and Efficacy of a Guided Bone Regeneration Membrane for the Treatment of Femoral Fractures
Certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. Many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue…
- Trial name
- NCT01687530
- Testing
- AMCA Bone Membrane.
- Where
- 2 sites in Israel
- Volunteers
- 48 people
- Sponsor
- RegeneCure, Ltd.
Orthopedic Disorder, Trauma Injury
X-BS Ortho Bone Graft Study
Randomised investigation of the osteoconductive performance and safety of CE-marked FDBS bone graft (GraftR3®), with contextual reference to CE-marked IBS (MBCP® Putty), in the filling of orthopaedic bone defects.
- Conditions
- Orthopedic Disorder, Trauma Injury, Extremity Injury
- Trial name
- NCT06326827
- Testing
- FDBS (GraftR3®), IBS (MBCP® Putty)
- Volunteers
- 200 people
- Sponsor
- Advanced Medical Solutions Ltd.
Fracture Healing
Study To Assess FRacTure Healing With SclerosTin Antibody - Hip
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.
- Trial name
- STARTT-Hip (NCT01081678)
- Testing
- Romosozumab
- Where
- 99 sites in United States, Argentina and 22 more
- Volunteers
- 332 people
- Sponsor
- Amgen