The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Not Applicable

Not yet recruiting

• Conditions: Deltoid Ligament; Sprain (Strain) (Ankle); Ankle Fractures
• Interventions: Procedure: Additional deep deltoid ligament suture

• Registration Number: NCT06568276
• Lead Sponsor: Ostfold Hospital Trust

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23
• Study Start: 2024-09-01
• Primary Completion: 2026-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Differences in radiological stability parameters with or without ligament suture at group level	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
Patient-reported functional outcome 1 year after injury	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))

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS)	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
General health state reported through a general (generic) Patient-reported outcome measure (PROM)	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.
VAS Pain	6 weeks, 3 months, 1, 2 and 5 years	scale limited by intervals of no pain (0) and worst imaginable pain (100)
Ankle Fracture Outcome of Rehabilitation Measure	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
Posttraumatic ankle arthritis	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)
Self-reported Foot and Ankle Score (SEFAS)	3 months, 1, 2 and 5 years	Ankle specific PROM based on 12 items, scale 0(worst) - 48 (best possible)

Trial Locations

Locations (1)

Oestfold Hospital Trust; 🇳🇴 Grålum, Postbox 300, Norway