The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Summary

Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.

Conditions

• Ankle Fractures
• Deltoid Ligament; Sprain (Strain) (Ankle)

Interventions

PROCEDURE

Additional deep deltoid ligament suture

The deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus.

Sponsors & Collaborators

• Sykehuset Innlandet HF

  collaborator OTHER

• Helse Nord-Trøndelag HF

  collaborator OTHER

• Helse-Bergen HF

  collaborator OTHER

• Norwegian Institute of Public Health

  collaborator OTHER_GOV

• Helse Stavanger HF

  collaborator OTHER_GOV

• Trondheim University Hospital

  collaborator OTHER

• Norwegian University of Science and Technology

  collaborator OTHER

• Alesund Hospital

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Ostfold Hospital Trust

  lead OTHER

Principal Investigators

• Frede Jon Frihagen, MD, PhD · Oestfold Hospital Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-20

Primary Completion

2026-12-31

Completion

2032-07-01

Countries

• Norway

Study Locations