In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for upper limb fractures. This trial is examining whether a medication called Iloprost, applied directly to the fracture site during surgery, can improve bone healing in patients with broken upper arm bones near the shoulder.
Clinical trial locations
Study on Iloprost for Improving Bone Healing in Patients with Upper Arm Fracture
This clinical trial is investigating whether a medication called Iloprost can improve the healing of fractures in the upper arm bone, specifically breaks near the shoulder area known as proximal humeral fractures. The study aims to determine if applying Iloprost directly to the fracture site during surgery is safe and whether it can enhance the bone healing process.
Main inclusion criteria:
- Adults between 40 and 80 years old, both men and women
- Patients scheduled for surgery using a PHILOS plate (a specific type of metal plate that stabilizes the fracture)
- Fractures classified as type 3 or 4 according to the Neer classification, which indicates more severe breaks
- Patients with an ASA Score of 2 or less, meaning they are in relatively good health before surgery
- Signed informed consent form agreeing to participate in the study
Main exclusion criteria:
- Patients who fall outside the specified age range
- Individuals who belong to vulnerable populations requiring extra protection or care
- Specific types of proximal humeral fractures that do not meet the study requirements
Focus and goal of the trial:
The trial follows a structured approach beginning with patient eligibility screening and consent. During the surgical procedure, Iloprost concentrate is applied directly to the fracture site. After surgery, patients are closely monitored for any adverse reactions or side effects. Regular follow-up assessments track the healing process by examining factors such as the alignment of the bone, pain levels, and overall quality of life. The study uses specific measurement tools including the Constant-Murley Score and the Disabilities of the Arm, Shoulder, and Hand score to evaluate recovery progress. The trial is expected to conclude by March 31, 2026, with final evaluations assessing both the safety and effectiveness of the treatment.
Investigational drug:
Iloprost is the medication being studied in this trial. It works by mimicking prostacyclin, a natural compound in the body that helps widen blood vessels and improve blood flow to the affected area. By enhancing blood flow, Iloprost may promote better and faster bone healing. In this study, the medication is applied in a concentrated form directly at the fracture site during surgery, rather than being given through the bloodstream. This local application approach is being tested to see if it can specifically target the healing process at the injury site while minimizing potential side effects elsewhere in the body.
Summary
There is currently one clinical trial ongoing for upper limb fractures, specifically focused on proximal humeral fractures near the shoulder. The trial is being conducted in Germany and represents an innovative approach to improving bone healing by using Iloprost, a medication typically used for other purposes, applied directly to the fracture site during surgery. The study is particularly focused on more severe fractures (Neer types 3 and 4) in middle-aged to older adults. The research aims to determine whether this local application of Iloprost can safely enhance the natural healing process and potentially improve patient outcomes in terms of bone alignment, pain reduction, and overall arm and shoulder function. Results from this trial could potentially lead to new treatment options for patients with this type of fracture in the future.
