Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

Not Applicable

Recruiting

• Conditions: Closed Fracture Dislocation, Tarsometatarsal Joint; Open Fracture Dislocation, Tarsometatarsal Joint
• Interventions: Procedure: Hardware removal

• Registration Number: NCT02374944
• Lead Sponsor: University of Calgary

Brief Summary

This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

Detailed Description

Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years.

Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR).

Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

Study Timeline

• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-27
• Study First Posted: 2015-03-02
• Study Start: 2018-01-23
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-09
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Subject has Lisfranc injury that was treated within 28 days of injury.
• Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation.
• The patient must be medically fit for anesthesia
• Subject is willing and able to provide written informed consent for trial participation
• Subject is willing and able to comply with the study protocol including return for all follow-up evaluations
• Subject may have a bony, ligamentous, or combined lisfranc injury
• Demonstrated instability of the lisfranc complex on static, stress view or CT radiography.
• Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon
• Adequate reduction to within 1mm of lisfranc complex at time of fixation
• Hardware across the midfoot (tarsal-metatarsal joints 1-3)

Exclusion Criteria

• Subject has a significant pre-existing foot injury
• Subject has a delay in initial treatment greater than 28 days from time of injury
• Subject has an active infection in the area of surgical approach requiring surgical debridement
• Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury)
• Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the Lisfranc complex
• Subject has a high risk of death from surgery (ASA physical status Class V)
• Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)
• Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
• Subject is pregnant
• There has been loss of fixation or reduction prior to enrollment
• Previous corrective foot surgery
• Associated fracture of calcaneus, talus, or tibial plafond.
• Pathologic fracture
• Loss of fixation or reduction prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hardware Removal	Hardware removal	Removal of hardware at 6 months.

Primary Outcome Measures

Name	Time	Method
SF-36	2 years	Patient reported measure on physical and mental status on 36 items across eight health domains.
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score	2 years	Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
VAS-FA - Visual Analog Scale Foot and Ankle	2 years	Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
VAS - Visual Analogue Scale (Patient Satisfaction)	2 years	Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	2 years	Cost of treatment and complications plus incremental costs up to 2 year follow up will be collected and compared with Quality Adjusted Life Years (QALYs)
Radiologic outcome	2 years	Radiographic measurement of the gap between 1st and 2nd metatarsals and maintenance of reduction on static and weight bearing xrays from index films at enrollment to 2 years.

Trial Locations

Locations (3)

Peter Lougheed Centre; 🇨🇦 Calgary, Alberta, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

South Health Campus; 🇨🇦 Calgary, Alberta, Canada