In short
Currently, there are 5 clinical trials examining different treatments and approaches for patients who have experienced hip fractures. These studies are exploring pain management techniques, medications to prevent constipation after surgery, iron supplementation to improve recovery, and treatments to strengthen bones and prevent future fractures. The trials are being conducted in Denmark, Spain, and Norway.
Clinical trial locations
- Denmark
- Norway
- Spain
Study on Preventing Constipation After Hip Fracture Surgery Using Bisacodyl and a Drug Combination for Post-Surgery Patients
This study is being conducted in Denmark and focuses on preventing constipation, a common problem after hip surgery. The trial compares two different oral laxative treatments to see which works better at preventing constipation in the days following surgery.
Who can participate: This study is open to patients aged 65 years or older who have undergone surgery for a hip fracture at one of two orthopedic departments in the Southern Region of Denmark. Participants must be able to speak and understand Danish.
Who cannot participate: Patients who are part of vulnerable populations requiring special protection are excluded from this study.
What the study involves: The trial is testing two types of laxatives. One treatment uses bisacodyl, a medication that stimulates bowel movements. The other is a combination treatment containing simeticone, sodium hydrogen carbonate, potassium chloride, sodium chloride, sodium sulfate anhydrous, and macrogol 4000, which work together to ease bowel movements. Participants will be randomly assigned to receive one of these treatments or possibly a placebo. The study will monitor how often patients need additional medication to manage constipation during the 72 hours after surgery.
Purpose: The goal is to identify which laxative treatment is more effective at preventing constipation after surgery, helping doctors improve patient comfort and care during recovery.
Study on the Effects of Ferric Derisomaltose on Mobility in Elderly Patients After Hip Fracture Surgery
This Danish study examines whether an intravenous iron treatment can help older adults recover their ability to move around after hip surgery. The study compares a single dose of ferric derisomaltose to a placebo.
Who can participate: Patients must be 65 years or older and have had surgery for a hip fracture in the upper part of the thigh bone. They must have a haemoglobin level of 6.5 mmol/L or less within 1 to 5 days after surgery. Participants should have been able to walk indoors independently before the fracture, with a New Mobility Score of 2 or more. They must speak and understand Danish and be able to provide informed consent.
Who cannot participate: Patients who are part of vulnerable populations are excluded.
What the study involves: Participants receive either a single intravenous dose of ferric derisomaltose (20 mg per kilogram of body weight) or a placebo. The treatment is given through an injection or infusion using sodium chloride solution. Researchers will track recovery of movement using the New Mobility Score at 4 weeks by phone and in person at 6 and 12 weeks. They will also measure haemoglobin levels, the need for blood transfusions, fatigue, quality of life, fear of falling, pain, and the ability to perform daily activities.
Purpose: The study aims to determine whether iron supplementation can improve mobility recovery and overall quality of life in older adults after hip surgery.
Study on the Safety of Levobupivacaine and Bupivacaine with Fentanyl for Anesthesia in Patients Over 65 Undergoing Hip Fracture Surgery
This Spanish trial compares two types of spinal anesthesia used during hip surgery in older patients. The study focuses on the effects of these anesthetics on the heart and blood circulation.
Who can participate: Patients must be 65 years or older and undergoing surgery for a hip fracture. They must be suitable for intradural anesthesia, which is determined during a pre-anesthetic visit. Participants should have a physical status classified between I and IV according to the American Society of Anesthesiologists. They must weigh more than 40 kg, be taller than 140 cm, and have a Body Mass Index less than 50 kg/m². Patients must have a condition related to the heart, lungs, kidneys, or hormone systems, and must have provided informed consent.
Who cannot participate: Patients younger than 65 years, those not undergoing hip surgery, and those from vulnerable populations are excluded.
What the study involves: Participants receive either isobaric levobupivacaine or isobaric bupivacaine, both combined with fentanyl, for spinal anesthesia. Levobupivacaine is given as a solution for injection or infusion, while bupivacaine is combined with epinephrine. During and after surgery, researchers monitor blood pressure, heart rate, oxygen levels, and other indicators of heart and blood vessel function. Monitoring continues for up to 48 hours after surgery to track any adverse events.
Purpose: The study seeks to ensure that the anesthesia used is safe and effective for older patients, providing valuable information on the best anesthesia practices for this age group.
Study on Pain Relief in Hip Fracture Surgery: Comparing Levobupivacaine Block with No Block for Patients Undergoing Hip and Proximal Femur Surgery
This Spanish study explores whether a specific pain relief technique can improve pain management during and after hip surgery. The trial compares the Erectus Spinae Plane Lumbar block to no regional pain block.
Who can participate: Patients must be over 18 years old and undergoing hip surgery. Both men and women can participate. Participants must be classified as ASA I-III, meaning they have low to moderate anesthetic risk. They must understand how to assess pain using the Visual Analogue Scale and must sign a consent form.
Who cannot participate: Patients not undergoing hip surgery and those from vulnerable populations who may not be able to give informed consent are excluded.
What the study involves: Participants are randomly assigned to receive either a lumbar Erectus Spinae Plane block using levobupivacaine or no regional block. The medication is administered as a solution for injection or infusion to block nerve signals in the back area. After surgery, pain levels are measured using the Visual Analogue Scale, with the goal of reducing pain by at least one point two hours after the operation. The study also tracks the need for additional pain medication, side effects, and patient satisfaction.
Purpose: The research aims to determine whether this nerve block technique can provide better pain control and improve recovery comfort for patients undergoing hip surgery.
Study on Zoledronic Acid for Patients with Hip Fractures: Evaluating Early Treatment Safety and Effectiveness
This Norwegian trial, known as the ZEBRA trial, investigates the optimal timing for administering zoledronic acid, a medication that strengthens bones, in patients who have had hip surgery.
Who can participate: Patients must be over 50 years old and have had one low-energy hip fracture resulting from a minor fall or accident. Surgery must have been performed within 72 hours after the fracture. Women aged 50-60 must be postmenopausal or not pregnant. Participants must have acceptable kidney function with an estimated GFR greater than 35 and normal blood calcium levels. They must be considered fit to complete the follow-up by the recruiting doctor. Either the patient or their next of kin must provide signed informed consent.
Who cannot participate: Patients from vulnerable populations requiring special protection are excluded.
What the study involves: Zoledronic acid is administered through an intravenous infusion. Participants are randomly assigned to receive the medication either within 5 days after surgery or 3 months post-surgery. The study monitors bone health by measuring bone turnover markers 12 months after treatment. Secondary assessments include mobility scores, incidence of fever, antibiotic use, new fractures, and hospital readmissions. The trial is expected to conclude by June 2026.
Purpose: The study aims to determine whether early administration of zoledronic acid is as effective as delayed treatment in maintaining bone strength and preventing further fractures.
Summary
These five clinical trials represent a comprehensive approach to improving care for hip fracture patients across different aspects of treatment and recovery. The studies are distributed across three European countries, with Denmark hosting two trials, and Spain and Norway each hosting additional studies.
A notable focus across these trials is on the specific needs of older adults, with most studies targeting patients aged 65 years or older. This reflects the reality that hip fractures predominantly affect the elderly population. The research addresses various stages of care, from anesthesia and surgery through post-operative complications and long-term bone health.
Pain management features prominently in the Spanish trials, which examine different anesthetic techniques and nerve blocks. Meanwhile, Danish researchers are investigating both immediate post-surgical concerns like constipation and longer-term recovery issues such as mobility and iron levels. The Norwegian study takes a broader view by examining bone health over a 12-month period.
Several medications are being tested across these trials, including bisacodyl and combination laxatives, ferric derisomaltose for iron supplementation, various local anesthetics like levobupivacaine and bupivacaine combined with fentanyl, and zoledronic acid for bone strengthening. This diversity of approaches highlights the multi-faceted challenges in hip fracture care and the ongoing effort to optimize treatment at every stage of recovery.
