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NCT Number: NCT06568276

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

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.

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Key information

Conditions

Ankle Fractures Ankle Injuries Deltoid Ligament; Sprain (Strain) (Ankle) Fractures, Bone Leg Injuries Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oestfold Hospital Trust, Grålum, Postbox 300, Norway

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About this study

During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically treated ankle fractures nowadays are on average more complex. The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. This repair also compensates for syndesmotic injury to some extent. The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies.

The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 planned prior to surgery

Treatment and study plan

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.

Primary outcomes

  1. Patient-reported functional outcome 1 year after injury

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

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

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

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

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

Secondary outcomes

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

    Time frame: up to 5 years

    The generic Euroquol EQ-5D (EQ 5D-5L) reports general health based on 5 items where Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.

  2. Posttraumatic ankle arthritis

    Time frame: 1,2 and 5 years

    Arthritis seen on weightbearing x-rays will be reported according to Kellgren Lawrence Scale (KGLS) (0 no arthritis to 4 severe/end stage arthritis with bone to bone contact and bone wear and osteophytes)

  3. VAS Pain

    Time frame: 6 weeks, 3 months, 1, 2 and 5 years

    scale limited by intervals of no pain (0) and worst imaginable pain (100)

  4. Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 1, 2 and 5 years

    We will use a version of the Mobility bank 2.1. The setup and calculation method is still not clear. We await further progress from the organization developing this PROM. We hope to get a computer adapted testing (CAT) version of this survey ready in a Norwegian version within the start of 1 year follow up in September 2025

  5. Self-reported Foot and Ankle Score (SEFAS)

    Time frame: 3 months, 1, 2 and 5 years

    Ankle specific PROM based on 12 items, scale 0(worst) - 48 (best possible)

  6. Ankle Fracture Outcome of Rehabilitation Measure

    Time frame: 3 months, 1, 2 and 5 years

    Ankle Specific PROM based on 15 main items where 0 is the worst index score and 100 the best

Other outcomes

  1. Complications

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

    Infection, suture anchor malplacement, delayed/non-union and reoperation rate will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Esten Konstad Haanæs, MD

CONTACT

[email protected]

+4799789013

Marius Molund, MD, PhD

CONTACT

[email protected]

+4790093988

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

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

Registry information

Official study title

The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures: Patient-reported Functional Outcome and Radiological Stability Measurements

Important dates

Study start
2024
Primary completion
2026
Study completion
2032
First posted
Aug 23, 2024
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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