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Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy: Randomized Control Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06086223
Enrollment
176
Registered
2023-10-17
Start date
2023-11-01
Completion date
2026-07-30
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures, Ankle Injuries, Arthroscopic Surgery

Keywords

functional outcomes of ankle fracture management, ankle scope, syndesmosis reduction, ankle ligaments evaluation

Brief summary

The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.

Detailed description

Acute ankle fracture is one of the commonest fractures of the lower limb. Anatomical reduction and stable fixation remain the main surgical treatment for unstable ankle fractures . However, its final outcomes are not as good as expected . Fracture malunion, failure to address the disrupted syndesmosis and associated ligamentous or chondral lesions can be reasons for poor surgical outcome. 1-mm of lateral talar shift lead to a 42% increase in contact stress, so the anatomic reduction is critical to the long-term integrity of the joint . It is difficult to assess 1 to 2 mm of mal-reduction with C-arm fluoroscopy. The best assessment of the syndesmotic reduction is performed with axial CT imaging of the ankle. Ankle arthroscopy is expected to be a more sensitive tool for syndesmotic disruption diagnosis and other intra-articular pathologies and as a guide for anatomical reduction of the syndesmosis . Several studies have reported the incidence of chondral lesions seen during ankle arthroscopy at the time of ankle fracture ORIF, but those studies report the role of arthroscopy as a diagnostic or predictive tool for patient outcome. Very few studies have discussed the rates of arthroscopic intervention, the procedures performed, and the association of these procedures with patient final functional outcomes .

Interventions

PROCEDUREankle arthroscopy with ORIF

we will go for fixation of the fracture with association of scope intervention pre and post fixation

PROCEDUREfracture ankle fixation without ankle arthroscopy

we will go for fixation of the fracture alone with no scope intervention

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited. The sealed opaque envelope method will be used for randomization.

Intervention model description

Based on determining outcome variable, the estimated minimum required sample size is 176 cases (88 cases in each group). The sample size was calculated using G\*power software 3.1.9.7., based on the following assumptions: the patient satisfaction rate was higher in those patients who underwent arthroscopy compared with ORIF alone (93% vs 75%, P ¼ .05) (5). Main statistical test is z test, Alpha = 0.05, Power = 0.95 Allocation ratio= 1.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients ≥16 years of age who will be managed operatively for: * rotational ankle fracture Danis-Weber classification B or C fibula fracture * fracture dislocation ankle * Fractures extending into the tibial plafond, * Talus fractures (body or neck) in our institution

Exclusion criteria

Pediatric fractures, Polytrauma patients, Fractures managed with closed-contact casting and, patients with lost follow up during this study

Design outcomes

Primary

MeasureTime frameDescription
American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score6 months and one year follow upAOFAS hindfoot score difference between the 2 groups at 6 months and one year postoperatively from 0 to 100 where higher value indicates better functional outcomes

Contacts

Primary ContactEl-Taher Alaa Eldin Ahmed Eid, assisstant lecturer
taheralaa92@gmail.com01004859149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026