Health TrialsbyHealthPanel

Talar Osteochondral Lesions With Pilon Fractures

ConditionPilon Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri-Columbia

About this trial

Patients with pilon fractures have a high incidence of talar osteochondral lesions. In this study, patients will undergo ankle arthroscopy at the time of external fixation. The objective is to help determine the incidence of these lesions with pilon fractures and to see if these nano-arthroscopy results change the plan for definitive treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years (skeletally mature) Tibial plafond fractures with impaction of the articular surface requiring external fixation for temporization AO/Orthopaedic Trauma Association (OTA) Fracture classification 43-C type fractures (excluding posterior pilon or supination-adduction type ankle fractures) Closed injury

Disqualifiers

Prior ankle surgery

Pre-existing ankle arthritis

Unstable polytrauma patients precluding safe temporization

Concomitant talus or calcaneus fractures identifiable on plain radiographs

Trial design

Design model

Single group

Treatments tested in this trial

  • Diagnostic Ankle Nano-Arthroscopy

    Procedure/Surgery

    Following placement of the external fixator, the Arthrex Nanoscope will be introduced into the tibiotalar joint to evaluate for osteochondral lesions

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Diagnostic Ankle Nano-ArthroscopyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The total number of patients with talar osteochondral lesions in patients with tibial plafond fractures as determined by using images from the nano-arthroscopy at the time of external fixation

Time frame
Perioperative

Secondary outcomes

1

The total number of patients that identification of osteochondral lesions (OCLs) influences surgical decision-making regarding timing, approach, or choice of definitive fixation technique by each surgeon.

This will be determined through six fellowship-trained orthopedic trauma or foot \& ankle surgeons who will independently review patient histories, radiographs, and computed tomography (CT) to develop a preoperative plan. They will then be shown the same cases with knowledge of OCL findings to determine whether this information alters their management strategy (yes or no).

Time frame
Perioperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri-Columbia

Lead sponsor

Arthrex, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now