FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation): Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Fractures Around the Ankle in the Frail Elderly - A Two-Part Prospective, Randomized, Multi-Center Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Short-Form 12 (SF-12).
研究概览
简要总结
This will be a multi-centre randomized controlled trial, with London Health Sciences Centre (LHSC) as the lead site. Elderly patients with complex ankle fractures who meet the inclusion criteria and provide consent will be randomized (through a web-based randomization system) to one of the two treatment arms. One group (Group A) will receive primary ankle fusion, and the second group (Group B) will receive primary ankle open reduction and internal fixation (ORIF). Patient important outcomes will be compared at one year post injury
The Investigators have amended the study to include a second part for patients with less complicated but still unstable ankle fractures. In this part, patients will be randomly assigned to receive either a procedure called ORIF or another one called retrograde intramedullary fibular nailing.
详细描述
At the current time, there are few prospective studies comparing primary ankle arthrodesis versus Open Reduction and internal fixation (ORIF) for the treatment of complex fractures around the ankle in the frail elderly who have significant co-morbidities.
An effective alternative to ORIF that results in improved function, less post-operative pain and a lower rate of complications is desirable, particularly in the setting of a severely compromised soft tissue envelope, osteopenia or significant co-morbidities. Emerging clinical evidence regarding primary ankle fusion is encouraging, suggesting several potential benefits over ORIF in severely compromised cases including lower post-operative pain scores, improved functional outcomes, lower complication rates, and high union rates. However, high level evidence confirming these potential benefits is lacking. The results of the proposed investigation would have significant implications for the management of orthopaedic trauma patients with fragility fractures around the ankle and may in fact challenge ORIF as the gold standard of treatment in some cases.
Aims & Hypotheses
Aims:
The Investigators aim to conduct a two-part, multi-center RCT comparing retrograde nailing to ORIF for unstable fractures around the ankle in frail or compromised older adults. The primary research questions are:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria - Both Parts:
- •(i) Age ≥ 60 years (ii) One or more of the following:
- •Severe soft tissue compromise
- •Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI> 40))
- •Frailty as defined by a Dalhousie Clinical Frailty Scale score ≥4
- •Part 1 Specific Inclusion Criteria:
- •(i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 43C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar)
- •Part 2 Specific Inclusion Criteria (i) Isolated fracture (within 4 weeks of injury): an AO/OTA type 44B2, B3, C1 or C2 ankle fracture
排除标准
- •Both Parts:
- •(i) Presence of vascular injury or pathologic fracture; (ii) Previous tibia pilon fracture or retained hardware in affected limb; (iii) Refusal to participate; (iv) Inability to obtain informed consent due to language barrier
研究组 & 干预措施
Part 1: Fusion Group
Primary arthrodesis: Subjects allocated to the fusion group will have insertion of a retrograde locked calcaneal nail. Tibiotalar joint preparation, bone grafting, subtalar preparation, and fibulectomy will not be performed unless deemed necessary by the treating surgeon.
干预措施: Primary ankle arthrodesis (fusion) (Procedure)
Part 2: Fibula
Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.
干预措施: Intramedullary Fibular Nailing (IMFN) (Procedure)
Control Group: Internal Fixation
ORIF will be performed using modern techniques for timing and staging of fixation, soft tissue and fibula management, surgical approaches, reduction techniques, and plate choice.
干预措施: ORIF (open reduction and internal fixation) (Procedure)
结局指标
主要结局
Short-Form 12 (SF-12).
时间窗: 1 year post-surgery.
• The primary outcome will be health related quality of life, measured by the SF-12 at one year post surgery. The SF12 measures patient reported, health related quality of life from 0 to 100, with higher scores indicating better physical and mental health functioning.
次要结局
- Numeric Pain Rating Scale(1 year post-surgery)
- Function IndeX (FIX-IT)(1 year post-surgery)
- PROMIS-Physical Function Short Form (PROMIS-PF), version 10a(1 year post-surgery)
- Euro-Qol-5 Dimension (EQ5D)(1 year post-surgery)
- Extended Timed-up and Go (TUG) Test(1 year post-surgery)
- Foot and Ankle Ability Measure (FAAM)([Time Frame: 1 year post-surgery])
- Olerud Molander Ankle Score (OMAS)(1 year post-surgery)
- Rate of complications(1 year post-surgery)