Ongoing Clinical Trials for Radius Fracture
Currently, there are 4 clinical trials investigating different approaches to managing radius fractures, including pain relief methods during bone realignment procedures and long-term safety of bone implants. These studies are taking place across Denmark, Luxembourg, and Norway, and involve both nerve block techniques and implant technologies to improve treatment outcomes for patients with wrist fractures.
Clinical trial locations
- Denmark
- Luxembourg
- Norway
Study on Brachial Plexus Nerve Block with Epinephrine and Lidocaine for Adults with Distal Radius Fracture Needing Closed Reduction
This trial is comparing two approaches for managing wrist fractures that need to be realigned without surgery. The study focuses on a procedure called closed reduction, where doctors manually realign the broken bone without making surgical cuts.
Who can join: Adults aged 18 or older with a broken wrist bone near the joint that requires closed reduction. Both men and women can participate.
Who cannot join: Patients whose fracture does not need immediate realignment, those outside the specified age range, or individuals who belong to vulnerable populations requiring special protection.
What the study tests: Researchers are investigating whether using a brachial plexus nerve block provides better pain management compared to standard care. The nerve block involves injecting a numbing solution containing epinephrine and lidocaine hydrochloride near the shoulder nerves, guided by ultrasound imaging. This procedure aims to block pain signals in the arm during the bone realignment.
Study goals: The main focus is to determine whether patients receiving the nerve block are less likely to need surgery within 90 days after the procedure. The study also monitors pain levels during the procedure, any complications, wrist function recovery, and overall patient outcomes over a three-month period.
Study on Long-term Safety of NVDX3 Implant for Patients with Distal Radius Fracture or Low-grade Degenerative Lumbar Spondylolisthesis
This is a long-term safety follow-up study for patients who previously received a bone implant called NVDX3 in earlier clinical trials. The study tracks participants over 10 additional years to ensure the implant remains safe over time.
Who can join: Patients who have already been implanted with NVDX3 as part of previous clinical trials and who agree to attend yearly follow-up visits for 10 years. Both men and women can participate.
Who cannot join: The study excludes patients with wrist fractures or certain spine conditions who have not previously received the NVDX3 implant in a core clinical trial.
What the study tests: NVDX3 is an osteogenic implant made from human donor tissue that supports bone growth and repair. The implant is surgically placed and works by promoting the body’s natural bone regeneration processes.
Study goals: The primary aim is to document any serious side effects or complications related to the NVDX3 implant over a 10-year period. Participants attend yearly safety visits where doctors assess their health and record any issues related to the implant. This information helps researchers understand the long-term safety profile of this bone graft substitute.
Study on Post-Surgery Pain Relief for Radius Fracture Patients Using Ropivacaine and Oxycodone
This trial examines pain management after surgery to repair wrist fractures using a metal plate. Researchers are testing different concentrations of a numbing medication to find the most effective dose for reducing post-surgical pain.
Who can join: Adult patients scheduled for volar plate surgery within 20 days of their wrist fracture. Eligible participants must have a Body Mass Index between 18 and 40, weigh at least 50 kg, and be able to communicate in a Scandinavian language. Patients should be generally healthy or have well-controlled medical conditions.
Who cannot join: The study does not accept patients with wrist fractures outside the specified criteria, those outside the target age range, or individuals from vulnerable populations.
What the study tests: Participants receive either a lower concentration (3.75 mg/ml) or higher concentration (7.5 mg/ml) of ropivacaine through a nerve block near the shoulder. This local anesthetic blocks pain signals from reaching the brain. Additional pain medications including oxycodone, etoricoxib, paracetamol, and dexamethasone are provided as needed.
Study goals: The main objective is to determine whether the concentration of ropivacaine affects pain intensity after surgery. Researchers track pain levels at multiple time points from immediately after surgery up to six weeks later, using standard pain rating scales. The study also evaluates how pain affects sleep quality, work ability, and daily activities.
Comparison of Lidocaine and Ropivacaine in Ultrasound-Guided Nerve Block for Patients with Wrist Fractures Requiring Closed Reduction
This study compares two different local anesthetic medications for pain control during the non-surgical realignment of broken wrist bones. Both medications are delivered through the same type of nerve block procedure.
Who can join: Adults aged 18 to 65 with a wrist fracture requiring closed reduction. Participants must be able to provide informed consent and receive a nerve block injection near the collarbone for pain relief.
Who cannot join: Patients younger than 18 or older than 65, those with known allergies to local anesthetics, multiple fractures, infection at the injection site, neurological disorders affecting the arm, blood clotting disorders, open fractures, chronic pain conditions, heart or lung disease, pregnancy or breastfeeding, previous surgery in the affected arm, or participation in another clinical trial within 30 days.
What the study tests: Researchers compare lidocaine with epinephrine against ropivacaine, both administered through an ultrasound-guided lateral infraclavicular brachial plexus block. Lidocaine works quickly but for a shorter duration, while ropivacaine provides longer-lasting pain relief. Both medications block nerve signals by preventing sodium channels in nerve cells from transmitting pain sensations.
Study goals: The study evaluates how effectively each medication controls pain during the bone realignment procedure. After receiving the nerve block, patients wait 45 minutes while doctors assess whether the medication has adequately numbed the area. The medical team then performs the closed reduction and applies a cast. Researchers measure the success rate of the nerve blocks and patient pain levels throughout the procedure.
Summary
The four ongoing clinical trials for radius fractures reflect a focused interest in improving pain management during and after treatment. Three of the four studies investigate different approaches to nerve blocks for pain control, exploring various local anesthetic medications including lidocaine, ropivacaine, and their combinations. Two trials are conducted in Denmark, specifically examining pain relief during closed reduction procedures, while Norway hosts a study focused on post-surgical pain management. Luxembourg contributes a unique long-term safety follow-up study for the NVDX3 bone implant.
The concentration of trials in Scandinavian countries suggests regional expertise in orthopedic pain management research. The studies demonstrate a clear research priority: optimizing pain control while minimizing surgical intervention. By comparing standard care against nerve block techniques and testing different medication concentrations, these trials aim to establish evidence-based protocols that could reduce patient discomfort and potentially decrease the need for surgical intervention in managing wrist fractures.
