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| Name | Class |
|---|---|
| Seinajoki Central Hospital | OTHER |
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This trial is designed to compare different treatments on Lisfranc fractures. The trial consist of 2 different strata. Stratum 1: In mild injuries the comparison is between conservative treatment and operative treatment with open reduction and internal fixation (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.
The aim of this study is to find out the most effective way to treat Lisfranc injuries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open reduction and internal fixation | Active Comparator | After operative treatment non-weightbearing cast immobilisation for 6 weeks. Cast will be changed after 2 weeks. After the 6 weeks cast will be replaced with orthotics. Orthotics will remain for 4 weeks. |
|
| Primary Arthrodesis | Active Comparator | After operative treatment non-weightbearing cast immobilisation for 6 weeks. Cast will be changed after 2 weeks. After the 6 weeks cast will be replaced with orthotics. Orthotics will remain for 4 weeks. |
|
| Conservative treatment | Active Comparator | Non-weightbearing cast immobilisation for 6 weeks. Cast will be changed after 2 weeks. After the 6 weeks cast will be replaced with orthotics. Orthotics will remain for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open reduction and internal fixation | Procedure | Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis |
| Measure | Description | Time Frame |
|---|---|---|
| AOFAS Midfoot Scale | Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score). | 12 months |
| AOFAS Midfoot Scale | Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Foot and Ankle | Between group differences in pain and function of the foot measured with Visual Analog Scale of the Foot and Ankle (FA VAS). FA VAS scale is a self-administered patient questionnaire based on 20 questions in three different question categories (pain, function and other complaints). The total value of all questions is 2000. This total value is divided with 20 resulting in a possible score from 0 to 100 points, where 100 is the perfect score. |
| Measure | Description | Time Frame |
|---|---|---|
| Additional procedures or complications | Number of patients with any additional procedure or complication of the treatment (implant removal, implant failure, any other reason of reoperation or complication of the treatment) | up to 24months |
Inclusion Criteria:
Stratum 1:
Stratum 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heikki-Jussi Laine, MD; PhD | Tampere University | Study Chair |
| Tiina Kaistila, MS | Tampere University | Study Chair |
| Ville Mattila, Professor | Tampere University | Study Chair |
| Antti Paakkala, MD;PhD | Tampere University | Study Chair |
| Heikki Mäenpää, Docent | Tampere University | Study Chair |
| Mikko Kirjavainen, MD; PhD | Dextra Fertility Clinic | Study Chair |
| Janne Jousmäki, MD | Seinajoki Central Hospital | Study Chair |
| Olli Väistö, MD; PhD | Seinajoki Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere University Hospital | Tampere | 33521 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38482816 | Derived | Ponkilainen V, Maenpaa H, Laine HJ, Partio N, Vaisto O, Jousmaki J, Mattila VM, Haapasalo H. Open Reduction Internal Fixation vs Primary Arthrodesis for Displaced Lisfranc Injuries: A Multicenter Randomized Controlled Trial. Foot Ankle Int. 2024 Jun;45(6):612-620. doi: 10.1177/10711007241232667. Epub 2024 Mar 14. | |
| 30126393 | Derived |
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| ID | Term |
|---|---|
| D018409 | Foot Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Primary arthrodesis | Procedure | Primary arthrodesis versus ORIF |
|
| Conservative treatment | Procedure | Conservative treatment versus open reduction and internal fixation |
|
| 12 months |
| VAS Foot and Ankle | Between group differences in pain and function of the foot measured with Visual Analog Scale of the Foot and Ankle (FA VAS). FA VAS scale is a self-administered patient questionnaire based on 20 questions in three different question categories (pain, function and other complaints). The total value of all questions is 2000. This total value is divided with 20 resulting in a possible score from 0 to 100 points, where 100 is the perfect score. | 24 months |
| VAS Pain | Between group difference in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 6 weeks |
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 10 weeks |
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 4 months |
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 6 months |
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 12 months |
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 24 months |
| Ponkilainen VT, Mattila VM, Laine HJ, Paakkala A, Maenpaa HM, Haapasalo HH. Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol. BMC Musculoskelet Disord. 2018 Aug 21;19(1):301. doi: 10.1186/s12891-018-2222-4. |