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Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

A Randomized Trial of Post-Operative Outcomes: Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888550
Enrollment
20
Registered
2009-04-27
Start date
2007-08-31
Completion date
2009-12-31
Last updated
2010-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibia Fracture

Brief summary

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience. The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.

Interventions

PROCEDUREPost-Op Splinting

Splint will applied post-operatively and will remain on for two weeks

PROCEDURENo Splinting

Patient will be discharged post-operatively without a splint on their lower leg.

Sponsors

Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail

Exclusion criteria

* Pregnant Women * Prisoners

Design outcomes

Primary

MeasureTime frame
Differences across time and between groups for pain and range of motion3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026