# APBA Kısa Özet

A multicenter randomized controlled trial (RCT) involving 50 adults with isolated displaced medial malleolar fractures (Herscovici type B/C) compared closed reduction and percutaneous fixation (CRPF) to open reduction and internal fixation (ORIF). At 6-month follow-up, no significant difference was observed in American Orthopedic Foot and Ankle Society (AOFAS) scores, radiological union, or overall complication rates. CRPF was associated with lower hardware discomfort (12% vs. 20%), but the study did not prespecify an equivalence margin, so findings should not be interpreted as evidence of statistical equivalence.

# Çalışma neyi araştırdı?

This study aimed to evaluate and compare the radiographic and functional outcomes of closed reduction and percutaneous fixation (CRPF) versus open reduction and internal fixation (ORIF) in the treatment of isolated displaced medial malleolar fractures. The investigation focused on clinical function as measured by AOFAS scores, radiological union at 6 months, and the incidence of postoperative complications.

# Yöntem

The trial was a multicenter RCT conducted across two hospitals. A total of 50 adult patients with isolated displaced medial malleolar fractures classified as Herscovici type B or C were enrolled and randomly assigned in a 1:1 ratio to either the CRPF group (Group A, n=25) or the ORIF group (Group B, n=25). The principal objectives were radiological union and clinical function evaluated by the AOFAS score at 6-month follow-up. Secondary outcomes included the incidence of postoperative complications and correlations with patient demographics and mechanism of injury. Radiographic assessment and clinical scoring were performed at baseline and at the 6-month mark.

# Temel bulgular

At the 6-month follow-up, the study found no significant difference in clinical or radiological outcomes between the CRPF and ORIF groups (p > 0.05). Regarding AOFAS outcomes, Group A (CRPF) had 13 excellent, 7 good, 4 fair, and 1 poor rating, while Group B (ORIF) had 12 excellent, 9 good, 3 fair, and 1 poor rating. Radiological union rates were comparable between groups. Secondary outcome data revealed similar complication profiles: wound infection occurred in 4% of the CRPF group versus 12% of the ORIF group; malunion/non-union was observed in 8% of CRPF versus 4% of ORIF; hardware discomfort was reported in 12% of CRPF versus 20% of ORIF; and deep venous thrombosis (DVT) occurred in 4% of CRPF versus 12% of ORIF. Additionally, comorbidities such as diabetes and hypertension were significantly associated with increased sequelae risk (p < 0.05).

# Bulgular ne anlama geliyor?

The findings suggest that for isolated displaced medial malleolar fractures, both CRPF and ORIF result in comparable clinical and radiological outcomes at 6 months. While CRPF was associated with a lower incidence of hardware discomfort, the overall clinical benefits between the two techniques are similar. However, the absence of a prespecified equivalence margin means these results do not formally demonstrate statistical equivalence. The study indicates that patient-specific factors, particularly the presence of diabetes and hypertension, may influence postoperative sequelae risk.

# Klinik önem

Clinically, the results offer orthopedic surgeons evidence-based options when selecting a surgical approach for displaced medial malleolar fractures. The lower hardware discomfort rate associated with CRPF may be a relevant consideration for patient counseling and surgical planning. However, the decision between CRPF and ORIF should be individualized based on fracture morphology, patient comorbidities, and surgeon expertise, as the study did not establish non-inferiority or equivalence formally.

# Sınırlılıklar

Several limitations must be considered when interpreting these findings. The study lacked a formal sample size calculation, and no equivalence margin was prespecified, meaning the results cannot be interpreted as evidence of statistical equivalence. The sample size of 50 patients may limit the power to detect rare complications or perform robust comorbidity analyses. Blinding was not reported, which could introduce performance or detection bias. Additionally, the follow-up period was limited to 6 months, and larger adequately powered trials with longer follow-up are required to confirm these outcomes and assess long-term functional results and implant survival.