Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06086223

Collaborator

(none)

176

Enrollment

Arms

32.9

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Fractures Ankle Injuries Arthroscopic Surgery	Procedure: ankle arthroscopy with ORIF Procedure: fracture ankle fixation without ankle arthroscopy	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Jul 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: those patients who will go for ORIF plus arthroscopy 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 we will go for fixation of the fracture with association of scope intervention pre and post fixation Other Names: ankle fracture fixation with arthroscopy
Experimental: patients who will go for ORIF without arthroscopy 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 we will go for fixation of the fracture alone with no scope intervention Other Names: ankle fracture fixation without arthroscopy

Arm

Intervention/Treatment

Experimental: those patients who will go for ORIF plus arthroscopy

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

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

Other Names:

ankle fracture fixation with arthroscopy

Experimental: patients who will go for ORIF without arthroscopy

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

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

Other Names:

ankle fracture fixation without arthroscopy

Outcome Measures

Primary Outcome Measures

American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score [6 months and one year follow up]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

El-Taher Alaa Eldin Ahmed Eid, Principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT06086223

Other Study ID Numbers:

Arthroscopy for ankle fracture

First Posted:

Oct 17, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by El-Taher Alaa Eldin Ahmed Eid, Principle investigator, Assiut University

functional outcomes of ankle fracture management

ankle scope

syndesmosis reduction

ankle ligaments evaluation

Additional relevant MeSH terms:

Fractures, Bone

Ankle Fractures

Ankle Injuries

Study Results

No Results Posted as of Oct 17, 2023