The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures

Not Applicable

Not yet recruiting

Conditions: Ankle Fractures
Deltoid Ligament
Sprain (Strain) (Ankle)

Registration Number: NCT06568276

Lead Sponsor: Ostfold Hospital Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
General health state reported through a general (generic) Patient-reported outcome measure (PROM);Posttraumatic ankle arthritis;VAS Pain;Patient-Reported Outcomes Measurement Information System (PROMIS);Self-reported Foot and Ankle Score (SEFAS);Ankle Fracture Outcome of Rehabilitation Measure