The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Launched by OSTFOLD HOSPITAL TRUST · Aug 20, 2024
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether repairing the deltoid ligament—a key ligament in the ankle—can improve outcomes for people with certain types of unstable ankle fractures. Ankle fractures are quite common, affecting about 1 in 800 people each year. The researchers want to find out if fixing the deltoid ligament helps patients recover better and reduces the chance of long-term issues like arthritis, which can make daily activities harder. By studying this, they hope to help patients regain their ability to walk and perform daily tasks, which could also save money for the community by reducing long-term care needs.
To participate in the trial, you need to be between 16 and 75 years old and speak Norwegian fluently. You must have a specific type of ankle fracture called a Weber type B fracture and be able to walk without aids before your injury. However, if you have had a serious previous injury to the same ankle, certain medical conditions, or if you may not be able to follow the study guidelines, you won't be eligible. If you join the trial, you can expect to be part of a study that aims to improve ankle fracture treatments and possibly enhance your recovery process.
Gender
ALL
Eligibility criteria
- • Inclusion criteria; fluent in oral and written Norwegian language
- • isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy class I.
- • Initial medial clear space (MCS)\>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation.
- • Pre-injury walking ability without aids.
- • Exclusion criteria
- • assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
- • previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery.
- • open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture.
- • neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity
- • fixation of tibial fragment or syndesmotic screw or suture button
About Ostfold Hospital Trust
Østfold Hospital Trust is a leading healthcare institution in Norway, dedicated to providing high-quality medical care and advancing clinical research. With a commitment to innovation and patient-centered practices, the trust facilitates a wide range of clinical trials aimed at improving treatment outcomes and enhancing healthcare delivery. By collaborating with multidisciplinary teams and leveraging state-of-the-art facilities, Østfold Hospital Trust plays a pivotal role in contributing to medical knowledge and improving the health of the communities it serves. Its focus on ethical standards and rigorous scientific methodology ensures that all research activities uphold the highest quality and safety standards.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Grålum, , Norway
Grålum, , Norway
Patients applied
Trial Officials
Frede Jon Frihagen, MD, PhD
Study Director
Oestfold Hospital Trust
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported