Fixation In-situ vs Removal for Midfoot Lisfranc Injuries (FIRM)
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|ClinicalTrials.gov Identifier: NCT03694288|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lisfranc Injuries||Procedure: Implant removal||Not Applicable|
This study is a multicenter, randomized clinical trial comparing implant retention (Retention Group) to scheduled implant removal (Removal Group) in 100 skeletally mature patients with Lisfranc injuries previously treated with screw and/or plate fixation. The primary outcome measure is the validated, patient-reported Foot and Ankle Ability Measure (FAAM) at 1-year post initial Lisfranc injury. Secondary outcome measures include: 1. American Orthopedics Foot and Ankle Midfoot Score (AOFAS), 2. patient-reported Visual Analogue Scale (VAS) for Foot and Ankle, 3. range of motion, 4. radiographic assessment of Lisfranc reduction, 5. comparative cost analysis between treatment groups. This study will follow patients for 1-year post-injury.
Patients, surgeons, employers, and administrators will benefit from an evidence-based approach to implant removal following operatively treated Lisfranc injuries. This study will allow orthopaedic surgeons to counsel patients regarding the advantages and disadvantages of implant retention compared with removal. This study will provide robust data to inform clinical decision making for surgeons and provide patients with information regarding expected functional outcomes following Lisfranc injuries.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is a multicenter randomized clinical trial comparing implant retention (Retention) to scheduled removal of implants (Removal) in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.|
|Masking:||None (Open Label)|
|Official Title:||The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries|
|Actual Study Start Date :||September 7, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Removal Group
The implant removal group will have surgery scheduled 6 months after their initial surgical fixation.
Procedure: Implant removal
Surgical Implant removal
No Intervention: Retention Group
The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.
- Foot and Ankle Ability Measure (FAAM) [ Time Frame: 24 months ]FAAM is a patient-reported outcome tool used to assess physical function at 24 months post initial Lisfranc surgery. This instrument includes 2 sub-scales: activities of daily living sub scale of 21 items and sport sub scale of 8 items. Answers for both scales are based on a Likert scale (4-0) of: 4) No difficulty, 3) Slight difficulty, 2) Moderate difficulty, 1) Extreme difficulty, and 0) Unable to do. Questions for which "N/A" is indicated are not counted. Two scores are reported, one for each sub scale. To calculate the score for either sub scale, the total number of points are added, divided by the number of possible points (84 for ADL and 32 for sports), and multiplied by 100. Higher scores reflect a higher level of physical function.
- American Orthopedics Foot and Ankle Midfoot Score (AOFAS) [ Time Frame: 24 months ]AOFAS is a surgeon-administered questionnaire, used for assessment of pain, function and alignment. The total score is reported. Scores range from 0 to 100, with a healthy midfoot receiving 100 points
- Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle [ Time Frame: 24 months ]VAS for Foot and Ankle is a validated tool for assessing pain intensity specific to foot injuries. The patient is asked to mark their current situation on a 10 cm line with anchor statements on the left (negative outcome) and on the right (positive outcome). Longer distances (from the "negative outcome" anchor point) represent a better outcome.
- Range of motion (ROM) [ Time Frame: 24 months ]Assessed buy surgeon
- Radiographic assessment of Lisfranc reduction [ Time Frame: 24 months ]Maintenance of reduction and degree of arthritic changes across Lisfranc complex (gap between 1st and 2nd metatarsals, between the lateral aspect of the medial cuneiform to the medial aspect of second metatarsal) will be assessed by comparison of index Xrays upon enrollment and follow-up X-rays.
- Comparative cost analysis between treatment groups [ Time Frame: 24 months ]Comparative cost of treatment and any complications plus incremental costs up to 2-year follow-up will be collected and compared between groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694288
|Contact: Prism Schneider, MD,PhD,FRCS(C)||email@example.com|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N 1N4|
|Contact: Prism Schneider, MD,PhD,FRCS(C)|