Posterior Malleolus Fractures (PMF) in Weber B Ankle Fractures - Fixation Versus no Fixation - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Self-Reported Foot and Ankle Score
研究概览
简要总结
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF.
Through a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients.
Mason and Molly type 2A and 2B fractures will be included in the study.
详细描述
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. Weber B fractures are the most common type of fracture of the fibula. A posterior malleolar fragment (PMF) is present in up to 46% of Weber B and Weber C fractures. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. Clinical outcome for ankle fractures with a PMF is known to be poor from several studies. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, PMFs have been treated with closed reduction, without direct manipulation of the PMF, and anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs.
The reason for focusing on the posterior approach is new knowledge that intraarticular step-off in the tibiotalar joint and malreduced syndesmosis is associated with poor outcomes. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. Pilskog et. al. published a retrospective study in Nov. 2020 where patients without fixation reported similar PROM to patients with fixation. Most studies are retrospective and with a variable number of patients without a reasonable conclusion as to what is best practice. A few prospective studies are published. But there are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF.
Through a multicenter, prospective, randomized controlled trial initiated from Haukeland University Hospital, patients with Weber B fracture and associated PMF (with or without a medial malleolus fracture) will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at seven study hospitals from all Regional Health Trusts in Norway.
Mason and Molly type 2A and 2B fractures will be included in the study. Type 2 fractures are medium-sized fractures of the posterior malleolus which involve the fibular incisura. The fractures are classified as type 2A if only the posterior malleolus is fractured and as type 2B if there are two posterior fragments of the tibia in which the medial fragment extends to and involves the medial malleolus.
The lack of consensus on best practice is of great concern as patients of all ages are affected. In a retrospective study examining the patient-reported outcome of 130 patients with a PMF, 75% were aged 67 or younger. Such an injury, therefore, affects patients with many active years left in both their working life and daily activities. Interviews with the patient representative and with patients at the outpatient clinic reveal a long time for rehabilitation, over 16-18 months until 100% working ability. The patients also talk about the need to change working tasks due to reduced range of motion and pain. The study will not only answer the best way to treat the PMFs, but also give insights into the impact on the patient's life through the use of sick leave, treatment of the ankle syndesmosis, and complication rates. The aim is to give the patients the best possible treatment for better recovery and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Posterior malleolar (PM) fracture, of Mason & Molly type 2A/2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture
- •Posterior malleoli >=2 mm displaced (on CT in axial, sagital or coronal plane)
- •Patients informed, written consent
- •Age 18-65 years
- •For inclusion axial CT images are examined
- •Measurements are performed 5 millimeters (mm) cranial to the tibia plafond
- •Posterior malleolus fractures involving less than 40% of the fibular notch are included.
排除标准
- •Non-compliant patient, i.e.: dementia, alcohol- or substance abuse
- •ASA-4 patients
- •Known congenital bone decease
- •Pathological fractures
- •Immunocompromised patients
- •Tourists or patients on a short-term work/study permit
- •Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction
- •Poor controlled diabetes
- •Patients with known arterial insufficiency
- •Open fractures
- •Severely traumatized patients (ISS>16)
- •Patient declines to participate in study
研究组 & 干预措施
Fixation group
Patients are placed in a prone position on the operating table. Fixation of the posterior malleolus fracture. Posterior, and/or lateral and medial malleolus fractures will be treated with open reduction and internal fixation. ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm. Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus. The posteromedial fragment in Mason and Molloy type 2B will be fixed with one or more screws, or plate, if this fragment is displaced more than 2 mm. A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced >2 mm depending on size and comminution of the fragment.
The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suture button.
干预措施: Fixation of the posterior malleolus fractures (Procedure)
Fixation group
Patients are placed in a prone position on the operating table. Fixation of the posterior malleolus fracture. Posterior, and/or lateral and medial malleolus fractures will be treated with open reduction and internal fixation. ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm. Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus. The posteromedial fragment in Mason and Molloy type 2B will be fixed with one or more screws, or plate, if this fragment is displaced more than 2 mm. A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced >2 mm depending on size and comminution of the fragment.
The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suture button.
干预措施: Fixation of lateral and/or medial malleolus fractures (Procedure)
Fixation group
Patients are placed in a prone position on the operating table. Fixation of the posterior malleolus fracture. Posterior, and/or lateral and medial malleolus fractures will be treated with open reduction and internal fixation. ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm. Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus. The posteromedial fragment in Mason and Molloy type 2B will be fixed with one or more screws, or plate, if this fragment is displaced more than 2 mm. A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced >2 mm depending on size and comminution of the fragment.
The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suture button.
干预措施: Syndesmotic fixation (Procedure)
Non-fixation group
Patients are placed in a supine position on the operating table. No fixation of the PMF. The PMF is reduced by ligamentotaxis. Lateral and/or medial malleolus fractures will be treated with ORIF if present.
ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm.
Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus.
A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced >2 mm depending on size and comminution of the fragment.
The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suturebutton.
干预措施: Fixation of lateral and/or medial malleolus fractures (Procedure)
Non-fixation group
Patients are placed in a supine position on the operating table. No fixation of the PMF. The PMF is reduced by ligamentotaxis. Lateral and/or medial malleolus fractures will be treated with ORIF if present.
ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm.
Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus.
A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced >2 mm depending on size and comminution of the fragment.
The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suturebutton.
干预措施: Syndesmotic fixation (Procedure)
结局指标
主要结局
Self-Reported Foot and Ankle Score
时间窗: 2 years postoperatively
Foot and ankle specific questionnaire with 12 questions with 5 levels. Total score from 0 (worst) to 48 (best).
次要结局
- EQ-5D 5L(Baseline, 12 weeks, 1 year, 2 years and 5 years postoperatively)
- Osteoarthritis(2 years and 5 years postoperatively)
- Change in Self-reported Foot and Ankle Score (SEFAS)(Baseline, 12 weeks, 1 year, and 5 years postoperatively)
- VAS of stiffness (0-100)(12 weeks, 1 year, 2 years and 5 years postoperatively)
- Dorsiflexion(6 weeks, 12 weeks, 2 years postoperatively)