Clinical trials: Lower Limb Fracture
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
Fragility Fracture, Hip Fractures
RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures.
- Conditions
- Fragility Fracture, Hip Fractures, Osteoporosis
- Trial name
- NCT04796350
- Testing
- AGN1 LOEP treatment
- Where
- 66 sites in Austria, Belgium and 9 more
- Volunteers
- 2,400 people
- Sponsor
- AgNovos Healthcare, LLC
Wrist Injury, Tibial Fracture
Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
- Conditions
- Wrist Injury, Tibial Fracture, Hip Injury
- Trial name
- TOMO (NCT01927575)
- Testing
- Standard X-Ray + CT, Standard X-Ray + MRI, TOMO
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fujifilm Medical Systems USA, Inc.
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
Bimalleolar Ankle Fractures
CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures
The OL1000 is intended to be used as a non-invasive adjunctive treatment for adult males or females that have sustained a closed, unstable ankle fracture that requires surgical treatment for stabilization.
- Trial name
- NCT02688855
- Testing
- Active Combined Magnetic Field OL1000 Bone Growth Stimulator
- Where
- 9 sites in United States
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Encore Medical, L.P.
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.
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, Hip Fracture
Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new)…
- Trial name
- NCT00046254
- Testing
- Zoledronic Acid
- Where
- 28 sites in United States, Germany
- Volunteers
- 2,127 people
- Sponsor
- Novartis Pharmaceuticals
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
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
Femoral Neck Fractures
Safety Study of Femoral Neck Fracture System
The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System.
- Trial name
- CONQUEST FN (NCT03721835)
- Testing
- CONQUEST FN Femoral Neck Fracture System
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Smith & Nephew, Inc.
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.
Rheumatoid Arthritis, Osteoarthritis
G7 BiSpherical Acetabular Shell PMCF Study
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis
- Trial name
- NCT03266874
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Femur Fracture
Pediatric Locking Nail for the Treatment of Femoral Fractures in Children
The purpose of this multi-center prospective clinical outcomes study is to determine validity and safety of the pediatric locking nail for femoral fracture management in children with open physes.
- Trial name
- PLN (NCT00725894)
- Testing
- Pediatric Locking Nail
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- Zimmer Biomet
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.
Hip Injuries, Fractures, Hip
Mitigation of Major Hip Injury Due to Fall With a Smart Belt
Multi-center, comparative, non-significant risk adaptive study with retrospective controls. After providing informed consent and being screened for eligibility, intervention subjects will be prescribed and provided an…
- Conditions
- Hip Injuries, Fractures, Hip, Fall Injury, Fall Risk
- Trial name
- NCT05245097
- Testing
- Tango Belt, Standard of Care (SOC)
- Where
- 10 sites in United States
- Volunteers
- 471 people
- Sponsor
- ActiveProtective Technologies, Inc
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.
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
Venous Thromboembolism, Embolism and Thrombosis
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
- Conditions
- Venous Thromboembolism, Embolism and Thrombosis, Hip Fractures
- Trial name
- NCT00119457
- Testing
- TTP889
- Where
- 21 sites in Czechia, Denmark and 2 more
- Volunteers
- 300 people
- Sponsor
- vTv Therapeutics
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