Clinical trials: Lower Limb Injury
Femur Fractures
The CHINA TFNA Study
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally.
- Trial name
- TFNA (NCT03635320)
- Testing
- TFNA, PFNA-II
- Where
- 9 sites in China
- Volunteers
- 188 people
- Sponsor
- Synthes GmbH
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
Femoral Fractures
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery.
- Trial name
- NCT00824564
- Testing
- Tranexamic Acid plus standard of care, Standard of care
- Where
- India
- Volunteers
- 82 people
- Sponsor
- Pfizer
Osteoarthritis, Hip, Fracture of Hip
Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System
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, Fracture of Hip, Avascular Necrosis of Hip, Dislocated Hip
- Trial name
- NCT04079114
- Testing
- Patients who received the Stafit Acetabular System
- Volunteers
- 166 people
- Sponsor
- Zimmer Biomet
Post-stroke Spasticity, Spasticity Post-Traumatic Brain Injury
Dysport® Adult Lower Limb Spasticity Follow-on Study
The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.
- Trial name
- NCT01251367
- Testing
- Botulinum toxin type A
- Where
- 50 sites in United States, Australia and 9 more
- Volunteers
- 352 people
- Sponsor
- Ipsen
Knee Injuries
Follow-Up Study Evaluating The Long Term Safety and Efficacy of BST-CarGel and Microfracture Repair of the Knee
This follow-up study will evaluate the effects of BST-CarGel® application to a microfractured lesion (investigational) and microfracture alone (control) for up to 5 years from treatment in subjects, treated under Protocols…
- Trial name
- NCT01246895
- Testing
- Microfracture with BST-CarGel, Microfracture without BST-CarGel
- Where
- 16 sites in Canada, Spain
- Volunteers
- 67 people
- Sponsor
- Piramal Healthcare Canada Ltd
Anterior Cruciate Ligament Tear
Bridge-Enhanced ACL Repair vs ACL Reconstruction
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
- Trial name
- NCT02664545
- Testing
- BEAR Scaffold, Tendon Graft
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Miach Orthopaedics
Spasticity
Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity
Phase 2/3, randomized, double-blind, placebo-controlled, single-treatment, multicenter trial assessing the efficacy and safety of MYOBLOC for the treatment of lower limb spasticity, in adults followed by an open-label extension…
- Trial name
- NCT04099667
- Testing
- Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 3; MYOBLOC
- Where
- 9 sites in United States, Hungary and 1 more
- Volunteers
- 40 people
- Sponsor
- Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC
Hip Osteoarthritis
OXINIUM◊ DH Total Hip Arthroplasty Pivotal Study
The purpose of this study is to monitor safety of the participants implanted with the OXINIUM◊ DH Hip System up to 10-years post-implantation
- Trial name
- NCT02353377
- Testing
- OXINIUM DH Hip System, BIOLOX◊
- Volunteers
- 413 people
- Sponsor
- Smith & Nephew, Inc.
Bone Fracture, Radius Fracture
Study on Wood-plastic Composite for Circumferential Casting
The purpose of study is to verify that WOODCAST Circular system performs safely and effectively in its intended use.
- Conditions
- Bone Fracture, Radius Fracture, Ankle Fracture
- Trial name
- WOODCAST (NCT01493167)
- Testing
- limb casting/splinting
- Where
- Finland
- Volunteers
- 97 people
- Sponsor
- Onbone Oy
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
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.
Wound
An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label.
- Trial name
- NCT03723603
- Testing
- Fibrillar collagen powder dressing
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Medline Industries
Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA)
Study to Evaluate the Safety and Efficacy of OR3O™ Dual Mobility System vs. Conventional Single Bearing Design Total Hip System
The purpose of this study is to compare OR3O™ Dual Mobility System to a conventional, single-bearing design Total Hip System in subjects who undergo Primary THA.
- Conditions
- Degenerative Hip Joint Disease, Rheumatoid Arthritis (RA), Femoral Neck Fractures, Avascular Necrosis of Femoral Head
- Trial name
- OR3O (NCT04941729)
- Testing
- OR3O™ - Dual Mobility System, Conventional
- Where
- 4 sites in China
- Volunteers
- 24 people
- 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
Diabetic Foot Ulcer
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally…
- Trial name
- NCT00764361
- Testing
- doxycycline
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- NanoSHIFT LLC
Hip Surgery Corrective, Knee Injuries
Prospective, Randomized Clinical Investigation of Two Different Postoperative Wound Dressings
The primary objective of this investigation is to evaluate if complications related to surgical wound are more common in the treatment group compared to the control group starting from operation day until last visit.
- Trial name
- MxBPo02 (NCT02653183)
- Testing
- Active Comparator: Aquacel Surgical, Experimental: Mepilex Border Post-Op
- Where
- 3 sites in Belgium, Sweden
- Volunteers
- 118 people
- Sponsor
- Molnlycke Health Care AB
Arm Spasticity
Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice
The aim of the study was to compare Dysport treatment results (as assessed by Modified Ashworth Scale (MAS) in the elbow joint 4 weeks post treatment) following two treatment techniques: the current clinical practice injection…
- Trial name
- NMJ (NCT01682148)
- Testing
- Botulinum toxin type A
- Where
- 23 sites in Denmark, Finland and 2 more
- Volunteers
- 100 people
- Sponsor
- Ipsen
Anterior Cruciate Ligament Injuries
Jewel ACL Post Market Clinical Follow Up Study
The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction.
- Trial name
- NCT04580290
- Testing
- JewelACL
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- Xiros Ltd
Thrombosis, Venous
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by…
- Trial name
- FONDACAST (NCT00843492)
- Testing
- Fondaparinux sodium, Nadroparin
- Where
- 122 sites in France, Germany and 4 more
- Volunteers
- 1,351 people
- Sponsor
- GlaxoSmithKline