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Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Primary Purpose

Ankle Fractures, Ankle Injuries, Arthroscopic Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ankle arthroscopy with ORIF
fracture ankle fixation without ankle arthroscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures focused on measuring functional outcomes of ankle fracture management, ankle scope, syndesmosis reduction, ankle ligaments evaluation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    those patients who will go for ORIF plus arthroscopy

    patients who will go for ORIF without arthroscopy

    Arm Description

    we will start with a standard ankle arthroscopy. A leg holder and ankle joint distractor will be used. We will start with the anteromedial portal and introduce the 4-mm scope into the ankle joint. Next, under direct visualization, and taking care to preserve any branches of the superficial peroneal nerve, we will perform the anterolateral portal. We will carry out a standard diagnostic ankle arthroscopy to evaluate the ankle cartilage, wash intra-articular haematoma, identify, and remove any intra-articular fracture fragments and loose bodies, perform dynamic ligamentous stress examinations while directly visualizing the syndesmosis, the deltoid ligament, and the lateral collateral ligament. Following fracture fixation, arthroscopy will be also used as a second look to evaluate the quality of both articular and syndesmotic reduction, perform any needed arthroscopic intervention for deltoid ligament injury or management of chondral lesions (OCLs)

    Posterior malleolus fractures will be addressed when it is present whatever its size. The fibula fractures will be fixated using either a posterolateral or direct lateral incision. Lag screws will be used when the fracture pattern allows, and all fractures will be also treated with a neutralization or antiglide plate depending on the pattern and approach. If a medial malleolus fracture is present, this will be addressed through a direct medial incision. These fractures will be either fixed with cannulated screws or tension band cerclage wiring or a plate and screw construct depending on the fracture pattern. Once all bony injuries will be stabilized, a Cotton test will be performed under live fluoroscopy to determine syndesmosis stability. If positive, the syndesmosis will be stabilized using fully threaded screws.

    Outcomes

    Primary Outcome Measures

    American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
    AOFAS 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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 7, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06086223
    Brief Title
    Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy
    Official Title
    Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy: Randomized Control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    July 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ankle Fractures, Ankle Injuries, Arthroscopic Surgery
    Keywords
    functional outcomes of ankle fracture management, ankle scope, syndesmosis reduction, ankle ligaments evaluation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    those patients who will go for ORIF plus arthroscopy
    Arm Type
    Experimental
    Arm Description
    we will start with a standard ankle arthroscopy. A leg holder and ankle joint distractor will be used. We will start with the anteromedial portal and introduce the 4-mm scope into the ankle joint. Next, under direct visualization, and taking care to preserve any branches of the superficial peroneal nerve, we will perform the anterolateral portal. We will carry out a standard diagnostic ankle arthroscopy to evaluate the ankle cartilage, wash intra-articular haematoma, identify, and remove any intra-articular fracture fragments and loose bodies, perform dynamic ligamentous stress examinations while directly visualizing the syndesmosis, the deltoid ligament, and the lateral collateral ligament. Following fracture fixation, arthroscopy will be also used as a second look to evaluate the quality of both articular and syndesmotic reduction, perform any needed arthroscopic intervention for deltoid ligament injury or management of chondral lesions (OCLs)
    Arm Title
    patients who will go for ORIF without arthroscopy
    Arm Type
    Experimental
    Arm Description
    Posterior malleolus fractures will be addressed when it is present whatever its size. The fibula fractures will be fixated using either a posterolateral or direct lateral incision. Lag screws will be used when the fracture pattern allows, and all fractures will be also treated with a neutralization or antiglide plate depending on the pattern and approach. If a medial malleolus fracture is present, this will be addressed through a direct medial incision. These fractures will be either fixed with cannulated screws or tension band cerclage wiring or a plate and screw construct depending on the fracture pattern. Once all bony injuries will be stabilized, a Cotton test will be performed under live fluoroscopy to determine syndesmosis stability. If positive, the syndesmosis will be stabilized using fully threaded screws.
    Intervention Type
    Procedure
    Intervention Name(s)
    ankle arthroscopy with ORIF
    Other Intervention Name(s)
    ankle fracture fixation with arthroscopy
    Intervention Description
    we will go for fixation of the fracture with association of scope intervention pre and post fixation
    Intervention Type
    Procedure
    Intervention Name(s)
    fracture ankle fixation without ankle arthroscopy
    Other Intervention Name(s)
    ankle fracture fixation without arthroscopy
    Intervention Description
    we will go for fixation of the fracture alone with no scope intervention
    Primary Outcome Measure Information:
    Title
    American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
    Description
    AOFAS 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
    Time Frame
    6 months and one year follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    El-Taher Alaa Eldin Ahmed Eid, assisstant lecturer
    Phone
    01004859149
    Email
    taheralaa92@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35097364
    Citation
    Smith KS, Drexelius K, Challa S, Moon DK, Metzl JA, Hunt KJ. Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy. Foot Ankle Orthop. 2020 Mar 2;5(1):2473011420904046. doi: 10.1177/2473011420904046. eCollection 2020 Jan.
    Results Reference
    background
    PubMed Identifier
    19859695
    Citation
    Zengerink M, Struijs PA, Tol JL, van Dijk CN. Treatment of osteochondral lesions of the talus: a systematic review. Knee Surg Sports Traumatol Arthrosc. 2010 Feb;18(2):238-46. doi: 10.1007/s00167-009-0942-6. Epub 2009 Oct 27.
    Results Reference
    background

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    Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

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