NCT04519242

Brief Summary

The aim of the proposed study is to define the optimal treatment for Lisfranc fracture-dislocation, either primary arthrodesis (PA) or open reduction and internal fixation (ORIF), regarding the quality of life, complications, functional outcomes, and cost-effectiveness. The investigators hypothesize that patients will have a better quality of life and fewer complications during follow-up when undergoing a PA for unstable fracture-dislocations in the Lisfranc midfoot joints compared to ORIF. Further, the investigators expect this approach to be more cost-effective than the operative stabilization with retaining the dislocated joints, as patients will be exposed to a reduced number of reinterventions and hospital stay and/or prolonged use of pain medication.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

August 13, 2020

Last Update Submit

June 25, 2021

Conditions

Lisfranc FractureArthrodesisInternal FixationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • The 5 level EQ-5D version (EQ-5d-5L) questionnaire

    This validated questionnaire (as defined by the EQ-5D-5L questionnaire) is a descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. When the patients has no problems at the dimension, f.e. mobility, this is coded as "1". LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems

    2-year follow up period

Secondary Outcomes (7)

  • American Orthopaedic Foot and Ankle Society Score (AOFAS)

    2 year follow up period

  • Foot And Ankle Disability Index (FADI)

    2 year follow up period

  • Alignment of the foot on weight-bearing X-rays

    2 year follow up period

  • Medical Consumption Questionnaire (MCQ)

    2 year follow up period

  • Occurrence of complications

    2 year follow up period

  • +2 more secondary outcomes

Other Outcomes (1)

  • Amount and type of secondary procedures

    2-year follow up period

Study Arms (2)

Patients enrolled in the ORIF group

ACTIVE COMPARATOR

Open reduction and internal fixation (ORIF), ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation, TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead.

Procedure: Surgery

Patients enrolled in the PA group

ACTIVE COMPARATOR

PA will be done by removal of the articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS).

Procedure: Surgery

Interventions

SurgeryPROCEDURE

ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead. PA will be done by removal of articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). Type and sequence of fixation of the involved rays as needed, partial or complete fixation as needed, judgement by treating surgeon.

Patients enrolled in the ORIF groupPatients enrolled in the PA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years
  • Acute Lisfranc fracture injury (\< 6 weeks after trauma)
  • Displaced or unstable with weight-bearing radiographs
  • Independent for activities of daily living (yes/no question)

You may not qualify if:

  • Open Lisfranc injury
  • Pure ligamentous Lisfranc injury
  • Non-displaced and stable with weight-bearing radiographs
  • Contra-indications for general or locoregional anesthetic techniques
  • Other fractures at the ipsilateral leg
  • Pre-existent abnormalities at the Lisfranc complex
  • Pre-existent immobility
  • Dependent on activities of daily living (due to dementia, Alzheimer, NYHA class IV angina and heart failure, oxygen-dependent COPD)
  • Rheumatoid arthritis
  • Pathologic fractures (metastasis, secondary osteoporosis)
  • Peripheral neuropathy and/or diabetes
  • Alcohol- or drug abuse preventing adequate follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, Netherlands

RECRUITING

Related Publications (1)

  • van den Boom NAC, Stollenwerck GANL, Evers SMAA, Poeze M. Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial. BMC Surg. 2021 Aug 12;21(1):323. doi: 10.1186/s12893-021-01320-1.

    PMID: 34384419DERIVED

MeSH Terms

Conditions

Ankylosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Noortje van den Boom, MD

CONTACT

0031620627189n.vandenboom@maastrichtuniversity.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 19, 2020

Study Start

June 25, 2020

Primary Completion

June 25, 2022

Study Completion

June 25, 2024

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)