Clinical trials: Lower Extremity Fractures
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
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
Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone.
- Trial name
- NCT00314236
- Testing
- BST-CarGel with Microfracture, Microfracture without BST-CarGel
- Where
- 18 sites in Canada, South Korea and 1 more
- Volunteers
- 80 people
- Sponsor
- Piramal Healthcare Canada Ltd
Primary Osteoarthritis, Post-Traumatic Arthritis
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study
This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.
- Conditions
- Primary Osteoarthritis, Post-Traumatic Arthritis, Inflammatory Joint Disease, Femoral Neck Fracture
- Trial name
- NCT03357445
- Testing
- Avantage Reload cup
- Where
- 4 sites in France, Slovenia
- Volunteers
- 500 people
- Sponsor
- Zimmer Biomet
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.
Hip Fracture
Hip Fracture Surgery and Oral Nutritional Supplements
Senior hip fracture patients are the most vulnerable to malnutrition and protein deficiency. Low protein intake, like vitamin D deficiency, contribute to an increased risk for hip fracture.
- Trial name
- HIATUS (NCT01505985)
- Testing
- Oral nutritional Supplement
- Where
- Switzerland
- Volunteers
- 24 people
- Sponsor
- Société des Produits Nestlé (SPN)
Femoral Fracture
Post Market Clinical Evaluation of Gamma 4
This is a prospective, multi-center, non-randomized, post-market clinical investigation of the Gamma 4 System. Neither subjects nor investigators are blinded to treatment.
- Trial name
- PEGASUS (NCT05523635)
- Testing
- Gamma4 Nailing System
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities
Compartment Syndrome Traumatic Lower Extremity, Compartment Syndrome Traumatic Upper Extremity
Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome
Compartment syndrome remains a very serious complication of lower extremity trauma and/or procedural cases that involved lower or upper extremity surgery.
- Trial name
- NCT04012723
- Testing
- MY01 Continuous Compartmental Pressure Monitor
- Where
- 5 sites in Canada
- Volunteers
- 100 people
- Sponsor
- MY01 Inc.
Osteoporosis
CONFIRM EXTENSION - Long-term Follow-up Study of Patients Treated with AGN1 LOEP
The study is designed as a multi-center study within Europe in up to 60 patients treated with the AGN1 LOEP Kit in CONFIRM. This will be a non-randomized and non-blinded study.
- Trial name
- NCT04511364
- Testing
- Clinical imaging is performed during the 24 and 60 month follow-up visits
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- AgNovos Healthcare, LLC
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
Tibial Fractures
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled.
- Trial name
- NCT04015167
- Testing
- T2 Alpha Tibia Nailing System
- Where
- 4 sites in United States
- Volunteers
- 103 people
- Sponsor
- Stryker Trauma and Extremities
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
Osteoporosis, Osteopenia
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects…
- Trial name
- NCT00330460
- Testing
- Alendronate, Denosumab
- Volunteers
- 1,189 people
- Sponsor
- Amgen
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
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, Malnutrition
Impact of a Nutritional Supplement on the Recovery of the Nutritional Status of Patients With Spontaneous Hip Fracture
Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.
- Trial name
- IRENE (NCT04183075)
- Testing
- FontActiv Superprotein/Hypercaloric Fiber, Carbohydrates and C Vitamin
- Where
- 2 sites in Spain
- Volunteers
- 82 people
- Sponsor
- Laboratorios Ordesa
Total Hip Arthroplasty, Degenerative Joint Disease of Hip
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and…
- Conditions
- Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip, Rheumatoid Arthritis of Hip
- Trial name
- NCT04754087
- Testing
- Vivacit-E and Longevity (HXLPE) Liners
- Where
- 11 sites in United States, Denmark and 3 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Fracture Healing, Treatment Duration
Smart Crutch Tips for Guided Weight-Bearing in Patients Recovering From Extra-Articular Distal 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 distal tibia fractures.
- Conditions
- Fracture Healing, Treatment Duration, Distal Tibia Fracture
- Trial name
- NCT07138066
- Testing
- Smart Crutch Tips™, Finite Element Analysis (FEA), Iterative walking
- Where
- 18 sites in Ukraine
- Volunteers
- 30 people
- Sponsor
- Comeback Mobility Inc
Tibial Fractures
Efficacy Study of Surgical Technique in Intramedullary Tibia Nailing, Using Trigen META Tibia Nails
Multicentre Prospective Randomized Clinical Trial, to evaluate patients after surgery for extra-articular tibial fractures treated with Smith\& Nephew's Trigen META intramedullary nailing system; comparing two surgical…
- Trial name
- TrigenMETA (NCT01358292)
- Testing
- Semi-extended Surgical Technique, Standard Surgical Technique
- Where
- 5 sites in Germany, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Smith & Nephew Orthopaedics AG
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