Study of Treatment of Lisfranc Injuries

Foot Injury Clinical Trial

Official title:

A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02953067
• Other study ID #: R11152
• Status: Terminated
• Phase: N/A
• Start date: March 2012
• Est. completion date: August 2023

Study information

• Verified date: November 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The aim of this study is to find out the most effective way to treat Lisfranc injuries

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Foot Injuries
• Foot Injury
• Wounds and Injuries

Intervention

Procedure:
• Open reduction and internal fixation
Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis
• Primary arthrodesis
Primary arthrodesis versus ORIF
• Conservative treatment
Conservative treatment versus open reduction and internal fixation

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Seinajoki Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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