ClinConnect ClinConnect Logo
Search / Trial NCT06568276

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.

Locations

Grålum, , Norway

Grålum, , Norway

Patients applied

0 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