Clinical trials: Lower Extremity Fractures
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
Hip Fractures, Gait Disorders in Old Age
Clinical Study of the Effects of a SWalker II and VR for Hip Fracture Rehabilitation in the Elderly
This project is structured in two distinct phases. The first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of…
- Trial name
- SWalker-VR (NCT06025981)
- Testing
- Preliminary Phase, Phase I - Early gait rehabilitation, Phase II - Maintenance gait function ( with VR)
- Where
- 2 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Werium Assistive Solutions
Muscle Wasting (Atrophy) After Hip Fracture Surgery
Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery
The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.
- Trial name
- NCT02152761
- Testing
- bimagrumab
- Where
- 53 sites in United States, Argentina and 17 more
- Volunteers
- 251 people
- Sponsor
- Novartis Pharmaceuticals
Total Hip Arthroplasty (THA), Hemiarthroplasty
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Primary Hip Prosthesis System in adult subjects undergoing…
- Conditions
- Total Hip Arthroplasty (THA), Hemiarthroplasty, Osteoarthritis (OA) of the Hip, Femoral Neck Fractures
- Trial name
- NCT07651735
- Testing
- Tipmed™ Primary Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 101 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
Tibial Fracture
Study Evaluating CERAMENT™|G in Open Diaphyseal Tibial Fractures
The purpose of this study is to demonstrate the safety and effectiveness of CERAMENT™|G used in conjunction with standard-of-care treatment compared to standard-of-care treatment alone in the care of subjects with open fractures…
- Trial name
- NCT02820363
- Testing
- CERAMENT|G, SOC treatment
- Where
- 31 sites in United States, Germany and 2 more
- Volunteers
- 201 people
- Sponsor
- BONESUPPORT AB
Hip Pain Etiology Unknown
Navigator vs Standard Needle Injection for Hip
The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a…
- Trial name
- NCT02066844
- Testing
- Celestone, Lidocaine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Cartiva, Inc.
Hip Osteoarthritis, Hip Disease
MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants…
- Conditions
- Hip Osteoarthritis, Hip Disease, Hip Fractures, Hip Injuries
- Trial name
- NCT04093739
- Testing
- G7 Freedom Constrained Liners
- Sponsor
- Zimmer Biomet
Hip Disease, Hip Fractures
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real…
- Trial name
- ESOP2 (NCT04193163)
- Testing
- Hip prosthesis - ESOP 2 cementless femoral stem
- Where
- 7 sites in France
- Volunteers
- 10 people
- Sponsor
- FH ORTHO
Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip
Avenir® Cemented Hip Stem - PMCF
The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Osteoarthritis of Hip, Femoral Neck Fractures, Femoral Head Necrosis
- Trial name
- NCT03396224
- Where
- 3 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Femoral Fracture
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of 50 subjects will be enrolled at up to 5 sites. Enrollment is estimated to commence in Q4 of 2018.
- Trial name
- NCT04015154
- Testing
- Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Stryker Trauma and Extremities
Fracture Femur, Fracture Tibia
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs.
- Trial name
- CETIULTRA-BONE (NCT07299851)
- Testing
- CFA-based food supplement
- Where
- 6 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Pharmanutra S.p.a.
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
Osteoarthritis, Hip, Rheumatoid Arthritis
Exception Cementless Hip Stem
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia
- Trial name
- Exception (NCT04349046)
- Testing
- Total hip arthoplasty (THA)
- Where
- 6 sites in Belgium, France
- Volunteers
- 332 people
- Sponsor
- Zimmer Biomet
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Healthy, Osteopenia
Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-BMD (NCT07187518)
- Testing
- Measurements with the POROUS R4C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine
- Where
- 2 sites in Germany
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Tibial Fractures
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Case series of tibial plateau fractures using Norian Drillable.
- Trial name
- NCT01132508
- Testing
- Norian Drillable Bone Void Filler
- Where
- 6 sites in Australia, China and 2 more
- Volunteers
- 33 people
- Sponsor
- Synthes GmbH
Fracture of Lower Limb
Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
- Trial name
- NCT01308047
- Testing
- Bupivacaine
- Where
- 2 sites in Brazil
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
Accidental Fall, Fall
Remote Monitoring and Analysis of Gait and Falls Within an Elderly Population
The investigators aim to do this initial pilot study as an observational prospective cohort study, evaluating elderly patients who have capacity in National Health Service (NHS) rehabilitation and community hospitals.
- Conditions
- Accidental Fall, Fall, Fall Injury, Hip Fractures
- Trial name
- 4279 (NCT03680014)
- Testing
- CUSH
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CUSH Health Ltd.
Pelvic Ring Fracture, Acetabular Fracture
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
- Conditions
- Pelvic Ring Fracture, Acetabular Fracture, Pelvic Fracture, Pelvic Fracture Acetabulum
- Trial name
- NCT05606042
- Testing
- IM Implant
- Where
- 6 sites in United States
- Volunteers
- 53 people
- Sponsor
- CurvaFix, Inc.
Fractures, Bone, Fractures, Closed
Post Market Evaluation of Clinical Safety and Performance of the Fitbone Transport and Lengthening System
This is an open-label, prospective, observational, post-market, uncontrolled, multi-center study intended to evaluate the safety and clinical performance of the FITBONE Transport and Lengthening Nail when used according to the…
- Conditions
- Fractures, Bone, Fractures, Closed, Fractures, Open, Fracture of Femur
- Trial name
- NCT06400732
- Testing
- Fitbone Transport and Lengthening System
- Where
- 9 sites in United States
- Volunteers
- 1 people
- Sponsor
- Orthofix Inc.