Foot Injury Clinical Trial
Official title:
A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries
NCT number | NCT02953067 |
Other study ID # | R11152 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2012 |
Est. completion date | August 2023 |
Verified date | November 2023 |
Source | Tampere University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 69 |
Est. completion date | August 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: Stratum 1: - Nondislocated fractures affecting tarsometatarsal (TMT) joints II and III - Dislocation <5mm between medial cuneiforme and base of II metatarsal (MT) - No fractures affecting TMT joints IV and V Stratum 2: - Affected joints TMT II- III + any other TMT - Any dislocation >2mm (fracture or TMT joint) - Dislocation >5mm between medial cuneiforme and base of II MT Exclusion Criteria: - Open fractures - Extra-articular metatarsal (MT) fractures - Extremely comminuted fractures with bone loss, and slight chance of gaining proper reduction with screws - Patients with multiple fractures - Patients with weak co-operation (dementia, alcohol use, etc.) - Patients with significant neuropathy or some other neurological condition, diabetes and rheumatoid arthritis - Patients with severe circulatory disorder of the lower limb - Injuries over 14 days - Patients with previous foot injury or surgery - Pregnancy - Patients who refuse to participate |
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital | Seinajoki Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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. | 12 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05444192 -
Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
|
N/A | |
Recruiting |
NCT05555459 -
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
|
N/A | |
Completed |
NCT06086418 -
Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
|
Phase 4 | |
Not yet recruiting |
NCT05762588 -
JuggerKnot With Broadband PMCF Study
|
||
Not yet recruiting |
NCT06352788 -
From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices
|
N/A | |
Completed |
NCT02645097 -
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
|
N/A | |
Completed |
NCT05190159 -
Monster Screw System Post-Market Clinical Follow-Up Study
|
||
Recruiting |
NCT06242002 -
Early Post-operative Monitoring by Sensor of Patients Undergoing Forefoot Surgery
|
N/A | |
Active, not recruiting |
NCT04967040 -
Reconstruction of Ankle and Foot Defects
|
N/A | |
Terminated |
NCT02643524 -
Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
|
N/A | |
Recruiting |
NCT06300671 -
The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance
|
N/A | |
Completed |
NCT05323773 -
How is Calf Muscle Endurance Related to Ankle Injuries in TeamGym Athletes?
|
||
Not yet recruiting |
NCT06304324 -
Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block
|
Phase 4 | |
Completed |
NCT05090059 -
Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)
|
N/A |