Clinical trials: Fixation
Dental Caries
Prevention of Enamel Demineralization by Use of K18-smooth Surface Sealant
This study will evaluate effectiveness of a urethane dimethacrylate (UDMA)-quaternary ammonium methacrylate (K18) resin (UDMA-K18) smooth surface sealant to prevent biofilm attachment to tooth surfaces thereby eliminating the…
- Trial name
- K18 (NCT03306433)
- Testing
- UDMA-K18 smooth surface sealant
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Bradycardia, Sinus Node Dysfunction
Safety and Performance Study of the INGEVITY Lead
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
- Trial name
- NCT01688843
- Testing
- INGEVITY lead
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,060 people
- Sponsor
- Boston Scientific Corporation
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
Subscapularis Peel, Morselized Osteotomy
Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.
- Trial name
- NCT00508105
- Testing
- subscapularis peel, osteotomy
- Where
- Canada
- Volunteers
- 87 people
- Sponsor
- Ottawa Hospital Research Institute
Surgery
Effect of Remifentanil on Hemodynamic Stability During Placement of a Mayfield Head Fixation Device for Craniotomy
To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.
- Trial name
- NCT02430389
- Testing
- Remifentanil, Normal Saline
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Northwestern University
Osteoarthritis
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems
The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.
- Trial name
- NCT00733499
- Testing
- LCS Complete Duofix, LCS Complete Porocoat
- Where
- Ireland
- Volunteers
- 206 people
- Sponsor
- DePuy International
Bunions, Postoperative Pain
Dose-Escalation Study of HTX-034 Following Bunionectomy
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl.
- Trial name
- NCT04398329
- Testing
- HTX-034 low dose, HTX-034 high dose, Luer lock applicator
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Heron Therapeutics
Fetal Alcohol Spectrum Disorder, Attachment Disorders
Evaluating the Effectiveness of an Attachment-Focused Intervention in Preschool Children With FASD
Study Summary: This study is being conducted in order to rigorously evaluate the real-world effectiveness of a publicly-funded, home-based, attachment-focused intervention Circle of Security (COS) Family Intervention Model…
- Trial name
- NCT01536184
- Testing
- Circle of Security (COS)
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- University of Manitoba
Acetabular Fracture, Heterotopic Ossification
Heterotopic Ossification Prophylaxis
One complication that can occur after surgery on the acetabulum is the development of bone in abnormal places such as muscle and soft tissues.
- Trial name
- NCT04867278
- Testing
- External Beam Radiation (XRT), Debridement
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- University of Maryland, Baltimore
Intertrochanteric Femur Fractures
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
There are approximately 250,000 hip fractures in the US every year, and intertrochanteric (IT) fractures (fractures that occur just below the femoral head) account for nearly half of these fractures.
- Trial name
- NCT02190435
- Testing
- Stryker ADAPT computer-assisted navigation, Conventional technique
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Corewell Health East
Bradycardia
INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
- Trial name
- NCT04346537
- Testing
- INGEVITY+™ Pace/Sense Lead
- Where
- 13 sites in United States
- Volunteers
- 109 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Congestive
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
- Trial name
- NCT00112125
- Testing
- OPTIMIZER System
- Where
- United States
- Volunteers
- 428 people
- Sponsor
- Impulse Dynamics
Fracture of Calcaneus, Pilon or Tibial Plateau
Vacuum Assisted Closure as a Treatment for Soft Tissue Injuries
This project is designed as a prospective, randomized, comparative study evaluating the use of a negative pressure vacuum device in treating soft tissue injuries and the surgical incision following open reduction and internal…
- Trial name
- VAC-ST (NCT00582998)
- Testing
- Standard Wound Dressing, Vacuum Assisted Closure Device
- Where
- United States
- Volunteers
- 249 people
- Sponsor
- University of Alabama at Birmingham
Distal Femur Fractures
Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation
The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS).
- Trial name
- NCT01693367
- Testing
- DLS 5.0 (Dynamic locking screws), SLS (Standard locking screw)
- Where
- 12 sites in United States, Austria and 2 more
- Volunteers
- 5 people
- Sponsor
- AO Innovation Translation Center
Maternal Depression, Child Behavior Problem
Attachment and Biobehavioral Catch-up and Depression Treatment
Maternal depression influences the development of children's behavior problems and vice versa; however most interventions singularly address maternal depression or children's behavior problems rather than both.
- Trial name
- ABC+D (NCT05096611)
- Testing
- Attachment and Biobehavioral Catch up, Attachment and Biobehavioral Catch up Plus Depression Treatment
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Femoral Fractures
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures
This study looks at two (2) types of surgical treatments and hopes to answer the question, "which is the best way to surgically treat a distal femur fracture?" Both procedures being studied are standard of care (used routinely)…
- Trial name
- NCT00429663
- Testing
- reamed, interlocking intramedullary nail, locking periarticular plate
- Where
- 22 sites in United States
- Volunteers
- 160 people
- Sponsor
- Boston Medical Center
Hip Fractures
Computer-Assisted Fixation of Trochanteric Femur Fractures
The purpose of this study is to assess whether the Stryker© ADAPT™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the Stryker© Gamma™ cephalomedullary nail.
- Trial name
- NCT04528459
- Testing
- Stryker© ADAPT™ platform, Traditional fluoroscopy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Columbia University
Neuropathy, Charcot; Disease (Etiology)
Lower Extremity Fixation In Neuropathic Patients Study
Prospective, multi-site, multi-year post-market clinical follow-up study on neuropathic patients treated/implanted with SALVATION™ External Fixation, SALVATION™ Fusion Bolts and Beams, SALVATION™ Midfoot Nail, The SALVATION™ 3Di…
- Trial name
- FINS (NCT04607044)
- Testing
- SALVATION™ EXTERNAL FIXATION
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Stryker Trauma and Extremities
Fracture Healing
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).
- Trial name
- STARTT (NCT00907296)
- Testing
- Romosozumab
- Where
- 103 sites in United States, Australia and 21 more
- Volunteers
- 402 people
- Sponsor
- Amgen
Maternal Behavior, Maternal Addiction
Oxytocin and Brain Responses in Maternal Addiction
A prior study by the principal investigator of this project identified dopamine- and oxytocin-related brain pathways that showed a diminished response when addicted mothers viewed the faces of their own vs.
- Trial name
- NCT02979093
- Testing
- Oxytocin, Functional MRI scanning
- Where
- 2 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Lane Strathearn, MBBS PhD