Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing

ConditionTibial Fractures

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorUniversity of Alabama at Birmingham

About this trial

The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 - 85 years

Stable Tibial fracture recommended for surgical intervention

Disqualifiers

Patients not meeting inclusion criteria

Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)

Previously non-ambulatory patients

Delayed presentation of fracture (>4 weeks)

Trial design

Design model

Single group

Treatments tested in this trial

micromotion intramedullary nail cohort
Procedure/Surgery
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal tibial interlocking screw
standard intramedullary nail cohort
Procedure/Surgery
use of at least 2 distal interlocking screws and the use of a minimum of 1 proximal interlocking screw

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Micromotion CohortExperimental treatment 1 intervention

Group B: Standard CohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The difference in radiographic union

bridging callus, minimum three cortices bridged

Time frame

12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively

Secondary outcomes

difference in complication rates

Patient reported outcomes scores

Time frame

1 year post-operatively

Sponsors and contacts

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

University of Alabama at Birmingham

Lead sponsor

Source ClinicalTrials.gov

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