Clinical trials: Fracture of Lower Limb
Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Study to Evaluate the Safety and Effectiveness of REAL INTELLIGENCE™ CORI™ in Unicondylar Knee Arthroplasty (UKA) Procedures
This is a prospective study to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Requires Correction of Functional Deformity
- Trial name
- CORI RCT UKA (NCT04797897)
- Testing
- CORI, Conventional
- Where
- 3 sites in Australia, Hong Kong and 1 more
- Volunteers
- 4 people
- Sponsor
- Smith & Nephew, Inc.
Venous Thromboembolism
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery
The primary objective was to compare the efficacy of once daily [q.d] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c.
- Trial name
- SAVE-HIP2 (NCT00721760)
- Testing
- Enoxaparin sodium, Semuloparin sodium
- Where
- 25 sites in United States, Argentina and 23 more
- Volunteers
- 1,003 people
- Sponsor
- Sanofi
Femoral Fractures, Hip Fractures
A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation.
- Trial name
- NCT04865146
- Testing
- TRIGEN™ INTERTAN™
- Where
- 7 sites in China
- Sponsor
- Smith & Nephew Medical (Shanghai) Ltd
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.
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures 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-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
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 Fracture
Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation
The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.
- Trial name
- NCT00521716
- Testing
- Intracapsular Femoral Fracture Fixation, WaisFix100i for Intracapsular Femoral Fracture Fixation
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- OrthoMediTec
Femur Fracture, Femur Fracture Intertrochanteric
THP Hip Fracture Plating System Study
The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.
- Conditions
- Femur Fracture, Femur Fracture Intertrochanteric, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
- Trial name
- THP (NCT03870477)
- Testing
- THP Hip Fracture Plating System with telescoping lag screws
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Zimmer Biomet
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
Tibial Fractures
ACTiF- Assessment of Closed Tibial Fractures
The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing…
- Trial name
- NCT00533377
- Testing
- CP-533, 536, Standard of Care, CP-533,536
- Where
- 56 sites in United States, Australia and 9 more
- Volunteers
- 276 people
- Sponsor
- Pfizer
Knee Injuries, Cartilage Injury
Clinical Study of Chondro-Gide® for Large Chondral Lesions in the Knee
Multi-center, prospective, concurrently controlled, non-randomized, double-blind (patient and assessor). Treatment of large chondral lesions in the knee with microfracture plus the Chondro-Gide® ACC is non-inferior to treatment…
- Conditions
- Knee Injuries, Cartilage Injury, Cartilage Disease, Knee Discomfort
- Trial name
- SECURE (NCT04537013)
- Testing
- Microfracture, Microfracture plus placement of Chondro-Gide® ACC
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 82 people
- Sponsor
- Geistlich Pharma AG
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
Hip Fracture
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.
- Trial name
- NCT01011608
- Testing
- Medical Food Supplement, standard hospital food
- Where
- 11 sites in Russia
- Volunteers
- 127 people
- Sponsor
- Abbott Nutrition
Hip Arthroplasty Replacement, Femoral Fractures
Cephalic Femoral Heads Follow Up
Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of cephalic femoral heads.
- Trial name
- NCT06873568
- Where
- Slovakia
- Volunteers
- 47 people
- Sponsor
- Limacorporate S.p.a
Venous Thromboembolism
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.
- Trial name
- NCT00937911
- Testing
- YM150
- Where
- 8 sites in Japan
- Volunteers
- 101 people
- Sponsor
- Astellas Pharma Inc
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
Femoral Fracture
A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 50 subjects will be enrolled.
- Trial name
- NCT04015128
- Testing
- Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System
- Where
- 6 sites in United States
- Volunteers
- 66 people
- Sponsor
- Stryker Trauma and Extremities
Osteoarthritis, Hip, Femur Head Necrosis
Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions.
- Conditions
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures
- Trial name
- NCT02288117
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 240 people
- Sponsor
- Waldemar Link GmbH & Co. KG
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
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