FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)

NCT05131321 | Recruiting

• 1 other identifier: 119571
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Numeric Pain Rating Scale

  1 year post-surgery

• Function IndeX (FIX-IT)

  1 year post-surgery

• Euro-Qol-5 Dimension (EQ5D)

  1 year post-surgery

• PROMIS-Physical Function Short Form (PROMIS-PF), version 10a

  1 year post-surgery

• Olerud Molander Ankle Score (OMAS)

  1 year post-surgery

Study Arms (3)

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.

Procedure: Primary ankle arthrodesis (fusion)

Part 2: Fibula

Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.

Procedure: Intramedullary Fibular Nailing (IMFN)

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.

Procedure: ORIF (open reduction and internal fixation)

Interventions

ORIF (open reduction and internal fixation) PROCEDURE

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.

Control Group: Internal Fixation

Intramedullary Fibular Nailing (IMFN) PROCEDURE

Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.

Part 2: Fibula

Primary ankle arthrodesis (fusion) PROCEDURE

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.

Part 1: Fusion Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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
• (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)

You may not qualify if:

• (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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Gene Fusion; Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Emil Schemitsch, MD, FRCS(C)

CONTACT

519-663-3307; emil.schemitsch@lhsc.on.ca

Abdel Lawendy, MD, FRCS(C)

CONTACT

519-685-8500; AbdelRahman.Lawendy@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 23, 2021
• Study Start: April 21, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-03

Locations

CA (1)