Who is sponsoring NCT03061279?

NCT03061279 is sponsored by Stanford University.

What drugs are being tested in NCT03061279?

Interventions in NCT03061279: Fixation by Acutrak headless screw, Fixation by headed screws, plates, and or wires.

What condition does NCT03061279 study?

NCT03061279 studies Medial Malleolus Fractures.

Is NCT03061279 still recruiting?

NCT03061279 is currently terminated. Last updated 22 October 2020.

Are results published for NCT03061279?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-22 · How we verify

NCT03061279

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

Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

Terminated NA Results posted Last updated 22 October 2020

What this trial tests

NA trial testing Fixation by Acutrak headless screw in Medial Malleolus Fractures in 1 participant. Terminated before completion.

Timeline

1 April 2017

Primary endpoint
26 October 2017

26 October 2017

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	1 April 2017
Primary completion	26 October 2017
Estimated completion	26 October 2017
Sites	3 locations across United States

Drugs / interventions tested

Fixation by Acutrak headless screw
Fixation by headed screws, plates, and or wires

Conditions studied

Medial Malleolus Fractures — all drugs for Medial Malleolus Fractures →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Medial Malleolus Fractures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. The investigators hope to learn the following objectives from this study 1. Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 3. Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 4. Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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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 NCT03061279 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 22 October 2020

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/NCT03061279.

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