The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures; Deltoid Ligament; Sprain (Strain) (Ankle)
• Intervention / Treatment: Procedure: Additional deep deltoid ligament suture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marius Molund, MD, PhD; Phone Number: +4790093988; Email: mariusmolund@hotmail.com
• Study Contact Backup: Name: Esten Konstad Haanæs, MD; Phone Number: +4799789013; Email: estenkh@gmail.com

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Aleksander Uchermann, MD; Phone Number: +47 95978404; Email: aleksander.uchermann@helse-bergen.no
    • Contact: Jostein Skorpa Nilsen, MD; Email: jostein.skorpa.nilsen@helse-bergen.no
  • Bodø, Norway
    • Recruiting
    • Nordlandssykehuset Bodø
    • Contact: Jonas Larsen Hilmo, MD; Email: jonashilmo@gmail.com
  • Elverum, Norway
    • Recruiting
    • Sykehuset Innlandet Elverum
    • Contact: Ove Talsnes, MD, PhD; Phone Number: 90951744; Email: ove.talsnes@sykehuset.innlandet.no
  • Gjøvik, Norway
    • Recruiting
    • Sykehuset Innlandet Gjøvik
    • Contact: Henrik E. W. Pettersen, MD; Phone Number: +4799402322; Email: hewild@sykehuset-innlandet.no
    • Sub-Investigator: Audun Dybvik Bøhn, MD
  • Levanger, Norway
    • Recruiting
    • Sykehuset Levanger
    • Contact: Esten Konstad Haanæs, MD; Phone Number: 99789013; Email: estenkh@gmail.com
    • Contact: Geir Steinstad, MD; Email: geir.steinstad@helse-nordtrondelag.no
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital Ullevål/Aker
    • Contact: Carl Erik Alm; Phone Number: +4799298431; Email: alm.carl.erik@gmail.com
    • Sub-Investigator: Mohammad Ballo, MD
  • Stavanger, Norway
    • Recruiting
    • Stavanger University Hospital
    • Contact: Aksel Paulsen, MD PhD; Phone Number: +47 98047438; Email: aksel.paulsen@sus.no
    • Contact: Kristianne Gjengedal, MD; Email: kristianne.runestad.gjengedal@sus.no
  • Ålesund, Norway
    • Recruiting
    • Ålesund Sjukhehus
    • Contact: Jakup Andreas Thomsen, MD; Email: jakup.andreas.thomsen@helse-mr.no
    • Contact: Ingrid Rieve Kristiansen, MD; Email: ingridrieve@gmail.com
  • Postbox 300
    • Grålum, Postbox 300, Norway, N-1714
      • Recruiting
      • Oestfold Hospital Trust
      • Contact: Frede Jon Frihagen, MD, PhD; Email: ffrihagen@gmail.com
      • Contact: Petter Pettersen, MD; Email: pettergh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional treatment; Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only
Experimental: Additional deltoid ligament suture; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	1,2 and 5 years
VAS Pain	scale limited by intervals of no pain (0) and worst imaginable pain (100)	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	1, 2 and 5 years
Self-reported Foot and Ankle Score (SEFAS)	Ankle specific PROM based on 12 items, scale 0(worst) - 48 (best possible)	3 months, 1, 2 and 5 years
Ankle Fracture Outcome of Rehabilitation Measure	Ankle Specific PROM based on 15 main items where 0 is the worst index score and 100 the best	3 months, 1, 2 and 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Infection, suture anchor malplacement, delayed/non-union and reoperation rate will be recorded.	especially on first visits after surgery ie 6 and 12 weeks, and later visits up to 5 years after surgery.

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Norwegian Institute of Public Health; Norwegian University of Science and Technology; Helse Stavanger HF; Sykehuset Innlandet HF; Helse Nord-Trøndelag HF; Alesund Hospital; Nordlandssykehuset HF; Helse-Bergen HF; Trondheim University Hospital
• Investigators: Study Director: Frede Jon Frihagen, MD, PhD, Oestfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures; Sprains and Strains
• Other Study ID Numbers: 2024104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No