Clinical trial NCT00556010: Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption
Official title: Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with fracture in the ankle with Syndesmosis disruption

Brief summary: Ankle fractures are common injuries that are being operated routinely. In order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. Inadequate reduction can result in pain and long term disability. Recently, based on MRI studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. We suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures.


Eligibility criteria: Inclusion Criteria:

1. Patients with unstable ankle fractures (as classified by the AO as 44B 44C by Lauge Hansen PER4 or SER4) amenable to open reduction and internal fixation.
2. Patients with syndesmotic rupture as evident from the injury films or during clinical testing in the OR be included in the study.
3. Intraoperative testing will include both a cotton Test and a stress view obtained after bimalleolar fixation has been attained.
4. A positive syndesmotic injury will be defined by the criteria of Pettrone et al as follows: a tib/fib clear space \>5mm or tib/fib overlap of \<10mm (on the AP view), or a tib/fib overlap of \<1mm on the mortise view.

Exclusion Criteria:

1. Patients with a pilon fracture (i.e. plafond fractures AO type 43B and C) will be excluded even if associated with a fibula fracture and syndesmosis disruption.
2. Patients with contraindications to operative treatment and diabetics
3. Women of childbearing age will be excluded if they present with a positive pre-op Beta HCG test or if they refuse a B HCG test.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization.
Study officials:
affiliation: Hadassah Medical Organization
name: Yorm A Weil, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU school of Medicine, Hospital for Joint Diseases , New York, U.S.A
name: Roy Davidovitch, MD
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Rami Mosheiff, MD
role: STUDY_CHAIR
affiliation: NYU school of Medicine, Hospital for Joint Diseases, New York, USA
name: Kenneth Egol, M.D
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Amal Khoury, MD
role: STUDY_CHAIR
affiliation: Hadassah Medical Organization
name: Meir Liebergall, MD
role: STUDY_DIRECTOR
References:
citation: Davidovitch RI, Weil Y, Karia R, Forman J, Looze C, Liebergall M, Egol K. Intraoperative syndesmotic reduction: three-dimensional versus standard fluoroscopic imaging. J Bone Joint Surg Am. 2013 Oct 16;95(20):1838-43. doi: 10.2106/JBJS.L.00382.