Clinical trial NCT05131321: Retrograde Nailing Versus Open Reduction and Internal Fixation for Unstable Fractures Around the Ankle in the Frail Elderly
Official title: PILON Study: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Fractures
Pilon Fracture
Keywords: Complex ankle fracture
Pilon fracture
Primary Ankle Arthrodesis
Fragility fracture
Elderly
Open reduction
Internal fixation
AO/OTA type 44B2, B3, C1 or C2 ankle fracture
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 172
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ankle fracture patients receiving care at the participating institutions will be eligible for enrolment based on the eligibility criteria.

Brief summary: 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.

Detailed description: 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:

Part 1: Does primary ankle fusion with a retrograde tibio-talar-calcaneal hindfoot nail for the treatment of severe fractures around the ankle (tibial pilon AO/OTA type 43 C2-3 or severe ankle fracture \[fracture dislocation, severe joint impaction, severe trimalleolar) in the frail elderly result in improved outcomes and a lower rate of complications compared with ORIF?

Part 2: Does primary retrograde intramedullary fibular nailing (IMFN) result in improved outcomes compared to ORIF for frail older adults with less complex (no dislocation, no significant joint impaction), but unstable fractures(AO/OTA type 44-B2-3, C1-2) around the ankle?

Hypotheses:

The Investigators hypothesize that:

1. Retrograde nailing will result in improved health related quality of life, functional outcomes, pain and reduced complications compared to ORIF.
2. Our null hypothesis is that retrograde nailing will not result in improved post-operative health related quality of life, functional outcomes, pain, and complication rates relative to ORIF for severe fractures around the ankle in the frail elderly.

Study Design

Design:

A two-part, multi-centre randomized clinical trial (RCT)

Procedure: Patients presenting to hospital with a suspected ankle fracture will be screened and those deemed potentially eligible will be approached for consent. Consenting patients will be enrolled prospectively over a 2-year period and followed according to the research ethics board (REB) approved protocol. Patients may also consent to be contacted at 5 years to evaluate long-term changes in outcomes. Full eligibility will be determined by an orthopaedic surgeon, following appropriate radiographic scans. The local research team will measure and capture outcomes during regularly scheduled clinic or hospital visits as well as through email/phone contact for patients consenting to contact via phone/email.

Eligibility criteria: 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 ≥5 \[13\]

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

Patient Exclusion Criteria - 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

Primary outcomes:
measure: Short-Form 12 (SF-12).
timeFrame: 1 year post-surgery.
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 1 year post-surgery
measure: Function IndeX (FIX-IT)
timeFrame: 1 year post-surgery
measure: Euro-Qol-5 Dimension (EQ5D)
timeFrame: 1 year post-surgery
measure: PROMIS-Physical Function Short Form (PROMIS-PF), version 10a
timeFrame: 1 year post-surgery
measure: Olerud Molander Ankle Score (OMAS)
timeFrame: 1 year post-surgery
measure: Extended Timed-up and Go (TUG) Test
timeFrame: 1 year post-surgery
measure: Rate of complications
timeFrame: 1 year post-surgery
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: [Time Frame: 1 year post-surgery]
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: