NCT07553221

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
60mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress2%
Apr 2026Apr 2031

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

April 15, 2026

Last Update Submit

April 30, 2026

Conditions

Pilon Fractures

Outcome Measures

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

    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.

    Perioperative

Study Arms (1)

Diagnostic Ankle Nano-Arthroscopy

EXPERIMENTAL

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

Procedure: Diagnostic Ankle Nano-Arthroscopy

Interventions

Diagnostic Ankle Nano-ArthroscopyPROCEDURE

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

Diagnostic Ankle Nano-Arthroscopy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Prior ankle surgery
  • Pre-existing ankle arthritis
  • Unstable polytrauma patients precluding safe temporization
  • Concomitant talus or calcaneus fractures identifiable on plain radiographs
  • Pregnant
  • Prisoner
  • Unable to Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65201, United States

Location

Related Publications (6)

  • El-Mowafi H, El-Hawary A, Kandil Y. The management of tibial pilon fractures with the Ilizarov fixator: The role of ankle arthroscopy. Foot (Edinb). 2015 Dec;25(4):238-43. doi: 10.1016/j.foot.2015.08.004. Epub 2015 Aug 20.

    PMID: 26442442BACKGROUND

  • Cha SD, Kwak JY, Gwak HC, Ha DJ, Kim JY, Kim UC, Jang YC. Arthroscopic Assessment of Intra-Articular Lesion after Surgery for Rotational Ankle Fracture. Clin Orthop Surg. 2015 Dec;7(4):490-6. doi: 10.4055/cios.2015.7.4.490. Epub 2015 Nov 13.

    PMID: 26640633BACKGROUND

  • Boraiah S, Paul O, Parker RJ, Miller AN, Hentel KD, Lorich DG. Osteochondral lesions of talus associated with ankle fractures. Foot Ankle Int. 2009 Jun;30(6):481-5. doi: 10.3113/FAI.2009.0481.

    PMID: 19486623BACKGROUND

  • Braunstein M, Baumbach SF, Regauer M, Bocker W, Polzer H. The value of arthroscopy in the treatment of complex ankle fractures - a protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2016 May 12;17:210. doi: 10.1186/s12891-016-1063-2.

    PMID: 27175917BACKGROUND

  • Aktas S, Kocaoglu B, Gereli A, Nalbantodlu U, Guven O. Incidence of chondral lesions of talar dome in ankle fracture types. Foot Ankle Int. 2008 Mar;29(3):287-92. doi: 10.3113/FAI.2008.0287.

    PMID: 18348824BACKGROUND

  • Martijn HA, Lambers KTA, Dahmen J, Stufkens SAS, Kerkhoffs GMMJ. High incidence of (osteo)chondral lesions in ankle fractures. Knee Surg Sports Traumatol Arthrosc. 2021 May;29(5):1523-1534. doi: 10.1007/s00167-020-06187-y. Epub 2020 Aug 6.

    PMID: 32761358BACKGROUND

Study Officials

  • Brett Crist

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vicki L Jones, MEd

CONTACT

573-882-7583jonesvicki@health.missouri.edu

Nash D Kolb

CONTACT

873-884-8428kolbn@health.missouri.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2031

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

US(1)