Clinical trial NCT06086223: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Fractures
Ankle Injuries
Arthroscopic Surgery
Keywords: functional outcomes of ankle fracture management
ankle scope
syndesmosis reduction
ankle ligaments evaluation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 176
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score
timeFrame: 6 months and one year follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.