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| Name | Class |
|---|---|
| Calgary Orthopaedic Research and Education Fund | OTHER |
| Memorial University of Newfoundland | OTHER |
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This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hardware Removal | Experimental | Removal of hardware at 6 months. |
|
| Hardware Retention | No Intervention | Retention of hardware at 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hardware removal | Procedure | Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score | 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. | 6 weeks |
| AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score | 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. | 12 weeks |
| AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score | 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. | 6 months |
| AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score | 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. | 1 year |
| AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score | 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. | 2 years |
| VAS-FA - Visual Analog Scale Foot and Ankle |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic outcome | 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. | 2 years |
| Cost-effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin Lienhard, PhD | Contact | 403-944-2932 | karin.lienhard@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Paul J Duffy, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | Canada |
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| ID | Term |
|---|---|
| D000098524 | Hardware Removal |
| ID | Term |
|---|---|
| D020878 | Device Removal |
| D013514 | Surgical Procedures, Operative |
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Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
| 6 weeks |
| VAS-FA - Visual Analog Scale Foot and Ankle | Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100. | 12 weeks |
| VAS-FA - Visual Analog Scale Foot and Ankle | Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100. | 6 months |
| VAS-FA - Visual Analog Scale Foot and Ankle | Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100. | 1 year |
| VAS-FA - Visual Analog Scale Foot and Ankle | Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100. | 2 years |
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 6 weeks |
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 12 weeks |
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 6 months |
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 1 year |
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 2 years |
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 6 weeks |
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 12 weeks |
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 6 months |
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 1 year |
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 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)
| 2 years |
| Peter Lougheed Centre | Active, not recruiting | Calgary | Alberta | Canada |
| South Health Campus | Active, not recruiting | Calgary | Alberta | Canada |