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TerminatedNCT00610701Updated Jul 24, 2017Results posted

Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

An interventional study of Anterior pin placement and Lateral pin placement in Fractures, Closed, sponsored by University of Missouri-Columbia. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment

Why this study was terminated
Extremely low enrollment and very little follow-up for meaningful data
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to evaluate patients with tibial plateau fractures.

Read the detailed description

The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.

Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.

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Conditions studied

  • Fractures, Closed

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03

In context

Fractures, Closed

44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.

This study's enrollment of 35 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.

Browse Fractures, Closed studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 365 studies on the registry; 69 are open to participants now.

Of its 43 completed or terminated interventional studies of FDA-regulated products, 29 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age and above (adult population)
  • All open and closed tibial plateau fractures

Exclusion criteria

Exclusion Criteria:

  • 17 years of age and less (pediatric population)
  • Quadriplegic patients
  • Vascular Injury to Extremity
  • Ipsilateral femur fractures
  • Ipsilateral Hip fractures
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Anterior pin placement

    Anterior pin placement

    Device: Anterior pin placement

  • Experimental
    Lateral pin placement

    Lateral pin placement

    Device: Lateral pin placement

Interventions

  • DeviceAnterior pin placement

    Anteriorly-placed (front of the leg) femoral external fixator pins

  • DeviceLateral pin placement

    Laterally-placed (side of the leg) femoral external fixator pind

06

What researchers measure

Primary outcomes

  1. Quadriceps Strength

    measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose

    Time frame: (admission, 6 weeks, 3 months, 6 months) 1 year

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Results

Posted Sep 10, 2014

Participant flow

Participant flow — Overall Study
Milestone1 Anterior2 Lateral
Started1520
Completed59
Not completed1011

Outcome measures

PrimaryQuadriceps Strength

measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose

Time frame:
(admission, 6 weeks, 3 months, 6 months) 1 year
Reported as:
Mean · Nm
Quadriceps Strength
Nm1-anterior Pin Placement2-lateral Pin Placement
Quadriceps Strength35.9 ± 10.739.6 ± 17.7
Statistical analysis
  • 1-anterior Pin Placement vs 2-lateral Pin Placement · t-test, 1 sided · p = >0.05

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1 Anterior—2/5 (40%)0/5 (0%)
2 Lateral—3/9 (33.3%)0/9 (0%)
Most frequent serious events
Most frequent serious events
Event1 Anterior2 Lateral
deathInjury, poisoning and procedural complications1/52/9
arthrofibrosisMusculoskeletal and connective tissue disorders1/50/9
infectionInfections and infestations0/51/9

Baseline characteristics

initially based on power analysis for anticipated quad strength data, final numbers based on those completing study in each group

Age, Categorical
Age, Categorical(Participants)1-anterior Pin Placement2-lateral Pin PlacementTotal
<=18 years000
Between 18 and 65 years5914
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)1-anterior Pin Placement2-lateral Pin PlacementTotal
Female257
Male347
Region of Enrollment
Region of Enrollment(participants)1-anterior Pin Placement2-lateral Pin PlacementTotal
United States5914
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Study locations

1 site
  • University of Missouri
    Columbia, Missouri 65212, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00610701
Responsible party
Brett Crist (Associate Professor, Co-Director of Trauma Services, Co-Director of Trauma Fellowship, Department of Orthopaedic Surgery, University of Missouri-Columbia) — Principal investigator
First posted
Feb 8, 2008
Start date
Mar 2006
Primary completion
Aug 2012
Completion
Feb 2014
Results posted
Sep 10, 2014
Last update
Jul 24, 2017

Study contacts

Brett Crist, MD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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