Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Sponsor
University of Missouri-Columbia (Other)
Overall Status
Terminated
CT.gov ID
NCT00610701
Collaborator
(none)
35
1
2
95.1
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate patients with tibial plateau fractures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures
Study Start Date
:
Mar 1, 2006
Actual Primary Completion Date
:
Aug 1, 2012
Actual Study Completion Date
:
Feb 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anterior pin placement Anterior pin placement |
Device: Anterior pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
|
| Experimental: Lateral pin placement Lateral pin placement |
Device: Lateral pin placement
Laterally-placed (side of the leg) femoral external fixator pind
|
Outcome Measures
Primary Outcome Measures
- Quadriceps Strength [(admission, 6 weeks, 3 months, 6 months) 1 year]
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18 years of age and above (adult population)
-
All open and closed tibial plateau fractures
Exclusion Criteria:
-
17 years of age and less (pediatric population)
-
Quadriplegic patients
-
Vascular Injury to Extremity
-
Ipsilateral femur fractures
-
Ipsilateral Hip fractures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Missouri | Columbia | Missouri | United States | 65212 |
Sponsors and Collaborators
- University of Missouri-Columbia
Investigators
- Principal Investigator: Brett Crist, MD, University of Missouri-Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Brett Crist,
Associate Professor, Co-Director of Trauma Services, Co-Director of Trauma Fellowship, Department of Orthopaedic Surgery,
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610701
Other Study ID Numbers:
- IRB 1059937
First Posted:
Feb 8, 2008
Last Update Posted:
Jul 24, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 1 Anterior | 2 Lateral |
|---|---|---|
| Arm/Group Description | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind |
| Period Title: Overall Study | ||
| STARTED | 15 | 20 |
| COMPLETED | 5 | 9 |
| NOT COMPLETED | 10 | 11 |
Baseline Characteristics
| Arm/Group Title | 1-anterior Pin Placement | 2-lateral Pin Placement | Total |
|---|---|---|---|
| Arm/Group Description | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind | Total of all reporting groups |
| Overall Participants | 5 | 9 | 14 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
5
100%
|
9
100%
|
14
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
40%
|
5
55.6%
|
7
50%
|
| Male |
3
60%
|
4
44.4%
|
7
50%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
5
100%
|
9
100%
|
14
100%
|
Outcome Measures
| Title | Quadriceps Strength |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1-anterior Pin Placement | 2-lateral Pin Placement |
|---|---|---|
| Arm/Group Description | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind |
| Measure Participants | 5 | 9 |
| Mean (Standard Deviation) [Nm] |
35.9
(10.7)
|
39.6
(17.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 1-anterior Pin Placement, 2-lateral Pin Placement |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.05 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
Adverse Events
| Time Frame | 1 year | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 14 patients completed the study | |||
| Arm/Group Title | 1 Anterior | 2 Lateral | ||
| Arm/Group Description | Anterior Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins | Lateral Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind | ||
All Cause Mortality |
||||
| 1 Anterior | 2 Lateral | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| 1 Anterior | 2 Lateral | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/5 (40%) | 3/9 (33.3%) | ||
| Infections and infestations | ||||
| infection | 0/5 (0%) | 0 | 1/9 (11.1%) | 1 |
| Injury, poisoning and procedural complications | ||||
| death | 1/5 (20%) | 1 | 2/9 (22.2%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||
| arthrofibrosis | 1/5 (20%) | 1 | 0/9 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| 1 Anterior | 2 Lateral | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/9 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Brett D. Crist, MD |
|---|---|
| Organization | University of Missouri |
| Phone | 5738826562 |
| cristb@health.missouri.edu |
Responsible Party:
Brett Crist,
Associate Professor, Co-Director of Trauma Services, Co-Director of Trauma Fellowship, Department of Orthopaedic Surgery,
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00610701
Other Study ID Numbers:
- IRB 1059937
First Posted:
Feb 8, 2008
Last Update Posted:
Jul 24, 2017
Last Verified:
Jun 1, 2017