Ankle FracturesFRAMENCT05131321
FRAME Study (Frailty-Related Ankle Fracture Management and Evaluation)
An observational study of Ankle Fractures and Pilon Fracture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ankle Fractures, Pilon Fracture
- What is being tested?
- Primary ankle arthrodesis (fusion), ORIF (open reduction and internal fixation) and Intramedullary Fibular Nailing (IMFN)
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2022to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ankle fracture patients receiving care at the participating institutions will be eligible for enrolment based on the 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 ≥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
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A5W9
Lawson Health Research Institute
About this study
Official title: 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
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.
Read the 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:
- Retrograde nailing will result in improved health related quality of life, functional outcomes, pain and reduced complications compared to ORIF.
- 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.
- Conditions
- Ankle Fractures, Pilon Fracture
- Being tested
- Primary ankle arthrodesis (fusion), ORIF (open reduction and internal fixation), Intramedullary Fibular Nailing (IMFN)
- 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
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary ankle arthrodesis (fusion)Procedure or surgery
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)Procedure or surgery
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.
Intramedullary Fibular Nailing (IMFN)Procedure or surgery
Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: ORIF (open reduction and internal fixation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post-surgery.
Secondary outcomes (8)
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.
Measured: 1 year post-surgery
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.
Measured: 1 year post-surgery
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.
Measured: 1 year post-surgery
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.
Measured: 1 year post-surgery
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.
Measured: 1 year post-surgery
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.
Measured: 1 year post-surgery
Rate of complications
- The rate of complications, including nonunion, malunion, infection, implant failure, arthritis, and re-operation will be captured.
Measured: 1 year post-surgery
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.
Measured: [Time Frame: 1 year post-surgery]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start21 Apr 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131321
- Sponsor's protocol ID
- 119571
- Acronym
- FRAME
- Status last verified
- Mar 2025
- First submitted
- 19 Oct 2021
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05131321
- Acronym / sponsor ID
- FRAME / 119571
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Retrograde nailing will result in improved health related quality of life, functional outcomes, pain and reduced complications compared to ORIF.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Fusion Group | – | 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. |
| Part 2: Fibula | – | Procedure: Intramedullary Fibular Nailing (IMFN)Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique. |
| Control Group: Internal Fixation | – | Procedure: ORIF (open reduction and 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ankle fracture patients receiving care at the participating institutions will be eligible for enrolment based on the eligibility criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Part 1: Fusion Group |
| 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. | Procedure or surgery | Control Group: Internal Fixation |
| Intramedullary Fibular Nailing (IMFN)Intramedullary Fibular Nailing: Participants allocated to the IMFN group will receive a locked fibular nail using a previously described technique. | Procedure or surgery | Part 2: Fibula |
Primary outcome
Short-Form 12 (SF-12).
Time frame: 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.
8 secondary outcomes
Numeric Pain Rating Scale
Time frame: 1 year post-surgery
Function IndeX (FIX-IT)
Time frame: 1 year post-surgery
Euro-Qol-5 Dimension (EQ5D)
Time frame: 1 year post-surgery
PROMIS-Physical Function Short Form (PROMIS-PF), version 10a
Time frame: 1 year post-surgery
Olerud Molander Ankle Score (OMAS)
Time frame: 1 year post-surgery
Extended Timed-up and Go (TUG) Test
Time frame: 1 year post-surgery
Rate of complications
Time frame: 1 year post-surgery
Foot and Ankle Ability Measure (FAAM)
Time frame: [Time Frame: 1 year post-surgery]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Fractures and Pilon Fracture, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emil Schemitsch, MD, FRCS(C) (519-663-3307, emil.schemitsch@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form 12 (SF-12). (time frame: 1 year post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.