NCT04519242 is a NA clinical trial of Surgery in Lisfranc Fracture, sponsored by Maastricht University Medical Center.

Who is sponsoring NCT04519242?

NCT04519242 is sponsored by Maastricht University Medical Center.

What drugs are being tested in NCT04519242?

Interventions in NCT04519242: Surgery.

What condition does NCT04519242 study?

NCT04519242 studies Lisfranc Fracture, Arthrodesis, Internal Fixation, Quality of Life.

Is NCT04519242 still recruiting?

NCT04519242 is currently status unknown. Last updated 29 June 2021.

Last reviewed 2021-06-29 · How we verify

NCT04519242

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The BFF Study- The Better to Fix or Fuse Study

Status unknown NA Last updated 29 June 2021

What this trial tests

NA trial testing Surgery in Lisfranc Fracture in 112 participants. Status unknown.

Timeline

25 June 2020

Primary endpoint
25 June 2022

25 June 2024

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	112
Start date	25 June 2020
Primary completion	25 June 2022
Estimated completion	25 June 2024
Sites	1 location across Netherlands

Drugs / interventions tested

Surgery

Conditions studied

Lisfranc Fracture — all drugs for Lisfranc Fracture →
Arthrodesis — all drugs for Arthrodesis →
Internal Fixation — all drugs for Internal Fixation →
Quality of Life — all drugs for Quality of Life →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Lisfranc Fracture or Arthrodesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Lisfranc injuries: fix or fuse? : a systematic review and meta-analysis of current literature presenting outcome after surgical treatment for Lisfranc injuries.
van den Boom NAC, Stollenwerck GANL, Lodewijks L, Bransen J, et al · · 2021 · cited 10× · PMID 34643414 · DOI 10.1302/2633-1462.210.bjo-2021-0127.r1
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.
van den Boom NAC, Stollenwerck GANL, Evers SMAA, Poeze M. · · 2021 · cited 5× · PMID 34384419 · DOI 10.1186/s12893-021-01320-1

Verify or expand the search:

Other trials of Surgery

Trials testing the same drug.

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NCT07419932 — Response to Neoadjuvant Treatment in Locally Advanced Thyroid Cancer · recruiting

Other recruiting trials for Lisfranc Fracture

Currently open trials in the same condition.

NCT05555459 — Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation · NA · recruiting

Other Maastricht University Medical Center trials

Trials by the same sponsor.

NCT04603261 — Time to Excretion of Contrast, a Maastricht Prospective Observational Study · withdrawn
NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04519242 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
Last refreshed: 29 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04519242.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing