Ensayo clínico comparando el uso de tornillos y del sistema TighRope® Knotless en el tratamiento de las lesiones agudas de la sindesmosis / A randomized clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis

Antecedentes y objetivo: Clásicamente el tratamiento de las lesiones agudas de la sindesmosis se ha realizado mediante tornillos. Hace unos años aparecieron implantes más flexibles que han evolucionado hasta el moderno TighRope® Knotless. El objetivo del presente estudio es comparar los resultados de ambos implantes. Material y métodos: Desde abril de 2019 hasta septiembre de 2020 reclutamos 68 pacientes diagnosticados de lesión aguda de la sindesmosis que fueron aleatorizados para tratamiento quirúrgico con tornillo o con TighRope® Knotless. Realizamos control posquirúrgico con tomografía axial computarizada, y a los 3, 6 y 12 meses se recogieron datos del rango articular, valores de escalas funcionales y se realizaron estudios de radiología simple. Resultados: Los pacientes tratados con tornillos no presentaban diferencias estadísticamente significativas en la escala AOFAS frente al grupo tratado con TighRope® Knotless a los 3 meses (83,1 vs. 81,80; p=1,03), ni a los 6 meses (88,27 vs. 88; p=0,26) ni a los 12 meses (93,03 vs. 92,10; p=0,93). Igualmente recogimos resultados similares en la escala de Olerud-Molander a los 3 meses (65 vs. 61,50; p=3,5), 6 meses (82,33 vs. 80,67; p=1,67) y 12 meses (92,67 vs. 90; p=2,67). Tampoco hubo diferencias en la tasa de malreducción posquirúrgica (ningún caso en ambos grupos), pérdida de reducción (3 en el grupo tratado con tornillo frente a 4 del grupo del TighRope® Knotless, p=0,54) o complicaciones (p=1). Conclusiones: El tratamiento de las lesiones agudas de la sindesmosis con tornillos o con TighRope® Knotless es similar tanto en resultados clínicos como radiológicos.(AU)

Background and aim: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. Material and methods: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomized to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. Results: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=,93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). Conclusions: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.(AU)

[Translated article] A randomised clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis / Ensayo clínico comparando el uso de tornillos y del sistema TighRope® Knotless en el tratamiento de las lesiones agudas de la sindesmosis

Antecedentes y objetivo: Clásicamente el tratamiento de las lesiones agudas de la sindesmosis se ha realizado mediante tornillos. Hace unos años aparecieron implantes más flexibles que han evolucionado hasta el moderno TighRope® Knotless. El objetivo del presente estudio es comparar los resultados de ambos implantes. Material y métodos: Desde abril de 2019 hasta septiembre de 2020 reclutamos 68 pacientes diagnosticados de lesión aguda de la sindesmosis que fueron aleatorizados para tratamiento quirúrgico con tornillo o con TighRope® Knotless. Realizamos control posquirúrgico con tomografía axial computarizada, y a los 3, 6 y 12 meses se recogieron datos del rango articular, valores de escalas funcionales y se realizaron estudios de radiología simple. Resultados: Los pacientes tratados con tornillos no presentaban diferencias estadísticamente significativas en la escala AOFAS frente al grupo tratado con TighRope® Knotless a los 3 meses (83,1 vs. 81,80; p=1,03), ni a los 6 meses (88,27 vs. 88; p=0,26) ni a los 12 meses (93,03 vs. 92,10; p=0,93). Igualmente recogimos resultados similares en la escala de Olerud-Molander a los 3 meses (65 vs. 61,50; p=3,5), 6 meses (82,33 vs. 80,67; p=1,67) y 12 meses (92,67 vs. 90; p=2,67). Tampoco hubo diferencias en la tasa de malreducción posquirúrgica (ningún caso en ambos grupos), pérdida de reducción (3 en el grupo tratado con tornillo frente a 4 del grupo del TighRope® Knotless, p=0,54) o complicaciones (p=1). Conclusiones: El tratamiento de las lesiones agudas de la sindesmosis con tornillos o con TighRope® Knotless es similar tanto en resultados clínicos como radiológicos.(AU)

Background and aim: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. Material and methods: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomized to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. Results: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=,93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). Conclusions: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.(AU)

[Translated article] A randomised clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis.

BACKGROUND AND AIM: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. MATERIAL AND METHODS: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomised to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. RESULTS: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=.93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). CONCLUSIONS: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.

A randomized clinical trial comparing screws and the TighRope® Knotless system in the treatment of acute injuries of syndesmosis. / Ensayo clínico comparando el uso de tornillos y del sistema TighRope® Knotless en el tratamiento de las lesiones agudas de la sindesmosis.

BACKGROUND AND AIM: Classically acute syndesmosis injuries have been treated using screws. A few years ago more flexible implants appeared evolving to current TighRope® Knotless. The primary aim of this study is to compare clinical and radiographic outcome of both implants. MATERIAL AND METHODS: From April 2019 to September 2020 68 patients diagnosed with acute syndesmosis injury were randomized to use screws or TighRope® Knotless. Syndesmosis reduction was assessed using bilateral CT potsoperatively. Outcomes were clinically and radiologically assessed at three, six, and twelve months after surgery. RESULTS: No significant differences were identified in the AOFAS Scale between groups at three months (83.1 vs. 81.80; P=1.03), nor at six (88.27 vs. 88; P=.26) or at twelve (93.03 vs. 92.10; P=,93). There were also no differences in Olerud-Molander scale at three (65 vs. 61.50; P=3.5), six (82.33 vs. 80.67; P=1.67) and twelve months (92.67 vs. 90; P=2.67). Likewise, there were no differences in rate of postoperative malreduction (no cases in both groups), loss of reduction (three cases in screw group vs. four in TighRope® Knotless group, P=.54) or complications (P=1). CONCLUSIONS: Treatment of acute syndesmosis injuries with screws or the TighRope® Knotless implant is similar in both clinical and radiological results.