NCT00888550

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

2.3 years

First QC Date

April 23, 2009

Last Update Submit

September 28, 2010

Conditions

Tibia Fracture

Outcome Measures

Primary Outcomes (1)

  • Differences across time and between groups for pain and range of motion

    3 months

Study Arms (2)

1. Splinting

EXPERIMENTAL
Procedure: Post-Op Splinting

2. No Splinting

ACTIVE COMPARATOR
Procedure: No Splinting

Interventions

Post-Op SplintingPROCEDURE

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

1. Splinting
No SplintingPROCEDURE

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

2. No Splinting

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Pregnant Women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 27, 2009

Study Start

August 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations

US(1)