The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

NCT06568276 | Recruiting DMC

• 1 other identifier: 2024104
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief 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)

Outcome Measures

Primary Outcomes (2)

• Patient-reported functional outcome 1 year after injury

  Function will be measured in Olerud-Molander Ankle Score (OMAS) (ankle specific) (0 (worst)-100 (best))

  1 and 2 years after injury, function 5 years after injury will also be collected

• Differences in radiological stability parameters with or without ligament suture at group level

  Differences in medial clear space (mm) on weightbearing x-rays or Gravity test at group level

  1 and 2 years after injury, function 5 years after injury will also be collected

Secondary Outcomes (6)

• General health state reported through a general (generic) Patient-reported outcome measure (PROM)

  up to 5 years

• Posttraumatic ankle arthritis

  1,2 and 5 years

• VAS Pain

  6 weeks, 3 months, 1, 2 and 5 years

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  1, 2 and 5 years

• Self-reported Foot and Ankle Score (SEFAS)

  3 months, 1, 2 and 5 years

Other Outcomes (1)

• Complications

  especially on first visits after surgery ie 6 and 12 weeks, and later visits up to 5 years after surgery.

Study Arms (2)

Conventional treatment

NO INTERVENTION

Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only

Additional deltoid ligament suture

EXPERIMENTAL

Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus and additional deep deltoid ligament suture

Procedure: Additional deep deltoid ligament suture

Interventions

Additional deep deltoid ligament suture PROCEDURE

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.

Additional deltoid ligament suture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 planned prior to surgery

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Sykehuset Innlandet HF: collaborator
• Helse Nord-Trøndelag HF: collaborator
• Helse-Bergen HF: collaborator
• Norwegian Institute of Public Health: collaborator
• Helse Stavanger HF: collaborator
• Trondheim University Hospital: collaborator
• Norwegian University of Science and Technology: collaborator
• Alesund Hospital: collaborator
• Nordlandssykehuset HF: collaborator

Study Sites (9)

Oestfold Hospital Trust

Grålum, Postbox 300, N-1714, Norway

RECRUITING

Ålesund Sjukhehus

Ålesund, Norway

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Nordlandssykehuset Bodø

Bodø, Norway

RECRUITING

Sykehuset Innlandet Elverum

Elverum, Norway

RECRUITING

Sykehuset Innlandet Gjøvik

Gjøvik, Norway

RECRUITING

Sykehuset Levanger

Levanger, Norway

RECRUITING

Oslo University Hospital Ullevål/Aker

Oslo, Norway

RECRUITING

Stavanger University Hospital

Stavanger, Norway

RECRUITING

MeSH Terms

Conditions

Ankle Fractures; Sprains and Strains

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Officials

• Frede Jon Frihagen, MD, PhD

  Oestfold Hospital Trust

  STUDY DIRECTOR

Central Study Contacts

Esten Konstad Haanæs, MD

CONTACT

+4799789013; estenkh@gmail.com

Marius Molund, MD, PhD

CONTACT

+4790093988; mariusmolund@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre Randomized Controlled Trial

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: August 23, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2032
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (9)