Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

NCT06086223 | Not Yet Recruiting

• 1 other identifier: Arthroscopy for ankle fracture
• Study Type: interventional
• Target: 176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ankle Fractures; Ankle Injuries; Arthroscopic Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months and one year follow up

Study Arms (2)

those patients who will go for ORIF plus arthroscopy

EXPERIMENTAL

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)

Procedure: ankle arthroscopy with ORIF

patients who will go for ORIF without arthroscopy

EXPERIMENTAL

* 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.

Procedure: fracture ankle fixation without ankle arthroscopy

Interventions

ankle arthroscopy with ORIF PROCEDURE

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

Also known as: ankle fracture fixation with arthroscopy

those patients who will go for ORIF plus arthroscopy

fracture ankle fixation without ankle arthroscopy PROCEDURE

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

Also known as: ankle fracture fixation without arthroscopy

patients who will go for ORIF without arthroscopy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 35097364 BACKGROUND

• 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.

  PMID: 19859695 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Central Study Contacts

El-Taher Alaa Eldin Ahmed Eid, assisstant lecturer

CONTACT

01004859149; taheralaa92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 17, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share