Clinical trials: Fracture of Lower Limb
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
Menopause, Vitamin D Deficiency
Effect of Consumption of Yogurt Fortified in Calcium and Vit. D on Circulating Levels of 25OHD in Postmenopausal Women
The purpose of this study is to evaluate the effect of daily consumption of one or two CALIN+ pot(s) versus no intake of product, after 4, 8, 12 and 16 weeks, on the evolution of the serum concentration of 25-hydroxy vitamin D…
- Trial name
- NCT02534064
- Testing
- CALIN+
- Where
- France
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Yoplait France SAS
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.
Distal Fibular Fracture, Bimalleolar Fracture
Comparison of Biodegradable & Metal Plates for Fixing Ankle Fracture
A randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the Inion OTPS FreedomPlateTM Biodegradable Fixation System versus…
- Conditions
- Distal Fibular Fracture, Bimalleolar Fracture, Trimalleolar Fracture
- Trial name
- NCT00864877
- Testing
- biodegradable fixation system (Inion OTPS FreedomPlateTM)
- Where
- United Kingdom
- Sponsor
- Inion Oy
Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic
Cemented TrendHip® - Multicenter PMCF Study on Total Indications
This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational…
- Conditions
- Coxarthrosis; Primary, Coxarthrosis; Post-Traumatic, Necrosis, Femur Head, Rheumatoid Arthritis
- Trial name
- TRESTI (NCT04943328)
- Testing
- Total Hip Arthroplasty
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- Aesculap AG
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
Treatment Duration, Fracture Healing
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Proximal Tibia Fractures
The goal of this clinical trial is to learn whether personalized weight-bearing prescriptions using Smart Crutch Tips™ can improve recovery after surgery for extra-articular proximal tibia fractures.
- Conditions
- Treatment Duration, Fracture Healing, Extra-articular Proximal Tibia Fractures
- Trial name
- NCT07134257
- Testing
- Smart Crutch Tips™, Finite Element Analysis (FEA), Iterative walking
- Where
- 18 sites in Ukraine
- Volunteers
- 30 people
- Sponsor
- Comeback Mobility Inc
Hip Osteoarthritis, Hip Arthropathy
Post Market Clinical Follow-up of EUROSTEM Femoral Stem
EUROSSTEM is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients…
- Conditions
- Hip Osteoarthritis, Hip Arthropathy, Hip Arthritis, Hip Necrosis
- Trial name
- NCT04995822
- Testing
- hip arthroplasty
- Where
- 9 sites in France
- Volunteers
- 131 people
- Sponsor
- EUROS
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
Hip Disease, Hip Fractures
MDR - M/L Taper With Kinectiv Technology Stems and Necks
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip…
- Conditions
- Hip Disease, Hip Fractures, Hip Injuries, Hip Arthritis
- Trial name
- NCT04027140
- Testing
- M/L Taper with Kinectiv Technology Stems and Necks
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Zimmer Biomet
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.
Fracture; Pelvic, Insufficiency Fractures
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
The purpose of this study is to evaluate outcomes in patients treated with iFuse TORQ TNT for pelvic fragility fractures.
- Conditions
- Fracture; Pelvic, Insufficiency Fractures, Fragility Fracture, Sacroiliac; Fusion
- Trial name
- REBAR (NCT07530497)
- Testing
- iFuse TORQ TNT Implant System
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- SI-BONE, Inc.
Sarcopenia in Elderly, Frailty
Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
This Phase II clinical study investigates the safety and effectiveness of a new drug, Isomyosamine, in patients with sarcopenia or frailty, conditions associated with aging and muscle weakness.
- Conditions
- Sarcopenia in Elderly, Frailty, Frailty/Sarcopenia, Frailty in Older Adults
- Trial name
- NCT06942182
- Testing
- Isomyosamine 250mg
- Volunteers
- 60 people
- Sponsor
- TNF Pharmaceuticals, Inc.
Hip Fractures, Intertrochanteric Fractures
EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture
This study evaluates the effect of EXPAREL on total opioid consumption through 72 hours following fascia iliaca compartment block (FICB) in subjects undergoing repair of intertrochanteric hip fracture.
- Trial name
- RESTORE (NCT03955458)
- Testing
- EXPAREL, Ropivacaine, Bupivacaine Hydrochloride
- Where
- United States
- Sponsor
- Pacira Pharmaceuticals, Inc
Hip Fractures
Effect of a Robotic Platform for Hip Fracture Rehab
Hip fracture is one of the most common traumas associated with falls in the elderly, severely affecting the patient's mobility and independence.
- Trial name
- NCT05079555
- Testing
- Robotic rehab
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Werium Assistive Solutions
Tibial Fracture
Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB®) Single Implantation in Tibial Fracture
Although the majority of tibial fractures heal normally, some fractures may not heal within the usual time frame and is known as delayed bone healing within 4 to 6 months and absence of bone healing within 9 to 12 months in the…
- Trial name
- ALLOB-TF2 (NCT04432389)
- Testing
- ALLOB
- Where
- 39 sites in Belgium, Czechia and 5 more
- Volunteers
- 178 people
- Sponsor
- Bone Therapeutics S.A
Osteoarthritis, Hip, Rheumatoid Arthritis
Avenir Müller Hip Stem Post Market Surveillance Study
This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Fracture of Hip, Dislocated Hip
- Trial name
- NCT04079127
- Testing
- Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Femoral Fractures, Hip Arthropathy
CoCrMo LOCK Bipolar Femoral Heads FU
Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads.
- Trial name
- NCT06885359
- Where
- Slovenia
- Volunteers
- 60 people
- Sponsor
- Limacorporate S.p.a
Distal Femur Fracture, Periprosthetic Fractures
Safety and Performance of the Biphasic Plate Distal Femur: A Multicenter Case Series
The goal of this observational multicenter case series is to assess the safety and performance of the CE-marked "Biphasic Plate Distal Femur" during standard of care.
- Conditions
- Distal Femur Fracture, Periprosthetic Fractures, Intra-Articular Fractures, Supracondylar Fracture
- Trial name
- NCT06028971
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 60 people
- Sponsor
- 41medical AG