The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorOstfold Hospital Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Additional deep deltoid ligament suture
Procedure/Surgery
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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Conventional treatmentNo intervention 0 interventions

Group B: Additional deltoid ligament sutureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Patient-reported functional outcome 1 year after injury

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

Time frame

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

Time frame

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

Secondary outcomes

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

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.

Time frame

up to 5 years

Posttraumatic ankle arthritis

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)

Time frame

1,2 and 5 years

VAS Pain

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

Time frame

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

Patient-Reported Outcomes Measurement Information System (PROMIS)

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

Time frame

1, 2 and 5 years

Other outcomes

Complications

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

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ostfold Hospital Trust

Lead sponsor

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

Source ClinicalTrials.gov

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