Clinical trials: Lower Limb Injury
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
Osteoarthritis of First Metatarsalphalangeal Joint
Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe
Evaluate and confirm the long-term safety and effectiveness of the Cartiva SCI implant established by the pivotal trial.
- Trial name
- MOTION (NCT02978573)
- Testing
- Cartiva
- Volunteers
- 135 people
- Sponsor
- Cartiva, Inc.
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
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.
Tibial Fractures, Open Fractures
Safety and Performance of BonyPid-1000™ in the Treatment of Gustilo I, II, IIIA and IIIB Tibial Open Fractures
This is a prospective, multi-national, multicenter, randomized, two arms, single blind, Standard of Care (SOC) controlled, with blinded central reading center study.
- Trial name
- NCT02491047
- Testing
- BonyPid-1000, Standard of Care (SOC) treatment
- Where
- 9 sites in Israel, Philippines
- Volunteers
- 51 people
- Sponsor
- PolyPid Ltd.
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
Diabetic Foot Ulcer
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
- Trial name
- ELITE (NCT07014176)
- Testing
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Where
- 8 sites in United States
- Volunteers
- 84 people
- Sponsor
- Cellution Biologics
Ankle Sprain
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.
- Trial name
- NCT00446797
- Testing
- Non-selective NSAIDS, Celecoxib
- Where
- 16 sites in Brazil, Costa Rica and 6 more
- Volunteers
- 278 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Athletes With Previous Lateral Ankle Sprain(s)
The Spraino Pilot Trial
This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.
- Trial name
- NCT03311490
- Testing
- Spraino
- Where
- 2 sites in Denmark
- Volunteers
- 510 people, healthy volunteers welcome
- Sponsor
- Spraino
Leg Spasticity
Dysport® Adult Lower Limb Spasticity Study
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
- Trial name
- NCT01249404
- Testing
- Botulinum toxin type A
- Where
- 62 sites in United States, Australia and 9 more
- Volunteers
- 388 people
- Sponsor
- Ipsen
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
Tibial Fractures
Bone Healing Accelerant Versus Standard of Care for Open Tibia Fractures
This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open…
- Trial name
- NCT03826784
- Testing
- BHA
- Where
- United States
- Sponsor
- Carmell Therapeutics Corporation
Ankle Sprain
FS-67 in the Treatment of Pediatric Patients With Ankle Sprain
The objective of this study is assess the efficacy and safety of single and multiple applications of the FS-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).
- Trial name
- NCT01037816
- Testing
- FS-67 Patch
- Where
- 23 sites in United States
- Volunteers
- 252 people
- Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
Acute Ankle Sprain
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
- Trial name
- NCT01272934
- Testing
- Diclofenac Sodium
- Where
- 6 sites in Germany
- Volunteers
- 205 people
- Sponsor
- Novartis
Spinal Cord Injuries, Paraplegia
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis
The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis.
- Conditions
- Spinal Cord Injuries, Paraplegia, Paralysis, Lower Limbs, Lower Extremity
- Trial name
- NCT04110561
- Testing
- Use of the Atalante exoskeleton
- Where
- 2 sites in France
- Volunteers
- 12 people
- Sponsor
- Wandercraft
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
Foot Fusion
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone…
- Trial name
- NCT00583375
- Testing
- Augment® Bone Graft, Standard of Care
- Where
- 37 sites in United States, Canada
- Volunteers
- 414 people
- Sponsor
- BioMimetic Therapeutics
Osteoarthritis, Rheumatoid Arthritis
Project JAY THA Registration Study
This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte ball head and SL-PLUS Stem in total hip…
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Avascular Necrosis
- Trial name
- NCT02347384
- Testing
- Delta PLUS Femoral Head + SL-TWIN Stem, BIOLOX forte ball head + SL-PLUS Stem
- Where
- 4 sites in China
- Volunteers
- 100 people
- Sponsor
- Smith & Nephew Orthopaedics (Beijing) Limited
ACL Tears
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
- Trial name
- NCT06948591
- Testing
- Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- CONMED Corporation