Primary Ankle Arthrodesis Versus Open Reduction and Internal Fixation for Fragility Fractures Around the Ankle in the Frail Elderly.

Ankle Fractures Clinical Trial

— PILON  

Official title:

PILON Study: Primary Ankle Arthrodesis Versus Open Reduction and Internal Fixation for Fragility Fractures Around the Ankle in the Frail Elderly: A Prospective, Randomized, Multi-Center, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131321
• Other study ID #: 119571
• Status: Recruiting
• Start date: April 21, 2022
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Emil Schemitsch, MD, FRCS(C)
• Phone: 519-663-3307
• Email: emil.schemitsch[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 compare primary ankle arthrodesis to ORIF for the treatment of complex fractures around the ankle in the frail elderly. The primary research question is:

1) Does primary ankle fusion for the treatment of severe fractures around the ankle in the frail elderly result in improved outcomes and a lower rate of complications compared with ORIF?

Hypotheses:

The Investigators hypothesize that:

1. Primary fusion will result in improved health related quality of life, functional outcomes, pain and reduced complications compared to ORIF.

2. 2) Our null hypothesis is that primary fusion 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 multi-centre randomized clinical trial (RCT)

Setting: London Health Sciences Centre - Victoria Hospital, ON (coordinating centre); other participating centres thus far include:

St. Michael's Hospital, ON, Winnipeg Regional Hospital, Winnipeg, MN, Royal Columbian Hospital, New Westminster, BC.

Procedure: The local research team will screen admissions and clinic lists for eligible patients who will be characterized and 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 during the primary appointment with an orthopaedic surgeon, following appropriate radiographic scans, at which point an informed consent discussion will take place. The local research team will measure and capture outcomes during regularly scheduled clinic or hospital visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

(i) Age = 60 years; (ii) Isolated fracture: an AO/OTA C2 or C3 tibial pilon fracture or severe ankle fracture (fracture-dislocation, severe joint impaction, severe trimalleolar) (iii) One or more of the following:

1. Severe soft tissue compromise

2. Significant co-morbidities (vascular disease + chronic trophic changes, diabetes + neuropathy, chronic renal failure, morbid obesity (BMI> 40))

3. Frailty as defined by a Dalhousie Clinical Frailty Scale score =5

Exclusion Criteria:

(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 provide informed consent; (v) Inability to obtain informed consent due to language barrier

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone
• Pilon Fracture

Intervention

Procedure:
• Primary ankle arthrodesis (fusion)
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.
• ORIF (open reduction and internal fixation)
ORIF: 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Form 12 (SF-12).	• 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.	1 year post-surgery.
Secondary	Numeric Pain Rating Scale	• Pain will be measured on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.	1 year post-surgery
Secondary	Function IndeX (FIX-IT)	• Weight-bearing will be assessed by the FIX-IT score, which provides a simple, standardized and validated approach to assess weight bearing and pain from 0 to 12 with 12 being no pain or weigh-bearing limitations.	1 year post-surgery
Secondary	Euro-Qol-5 Dimension (EQ5D)	• Health-related quality of life will also be measured by the EQ5D. The EQ5D measures patient-reported health related quality of life from 0 to 100, with 100 being the best health imaginable.	1 year post-surgery
Secondary	PROMIS-Physical Function Short Form (PROMIS-PF), version 10a	• Patient-reported function will be measured via the PROMIS-PF Short form, a rigorously developed, patient-centred measure that measures functional ability from 10 to 50, with 50 being no functional limitations.	1 year post-surgery
Secondary	Olerud Molander Ankle Score (OMAS)	• Patient-reported, ankle fracture specific functional ability will be measured by the OMAS. The OMAS is scored from 0 to 100 with higher scorings representing better functional ability.	1 year post-surgery
Secondary	Extended Timed-up and Go (TUG) Test	• Patient mobility will be measured by the Extended TUG test. To ensure that the investigators remain unbiased during the evaluation and follow-up process, the TUG test will be administered by independent assessors blinded to treatment allocation. The TUG test record the amount of time a patient requires to stand from a chair, walk 3 metres, turn and walk back to sit on the chair. The patient is allowed to use their regular walking aids, and the use of walking aids is recorded by the assessor. A shorter time represents better patient mobility.	1 year post-surgery
Secondary	Rate of complications	• The rate of complications, including nonunion, malunion, infection, implant failure, arthritis, and re-operation will be captured.	1 year post-surgery
Secondary	Foot and Ankle Ability Measure (FAAM)	• Patient-reported, ankle fracture specific functional ability will be measured by the OMAS. The OMAS is scored from 0 to 100 with higher scorings representing better functional ability.	[Time Frame: 1 year post-surgery]