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
The purpose of this study is to evaluate patients with tibial plateau fractures.
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.
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 →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.
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Exclusion Criteria:
Anterior pin placement
Device: Anterior pin placement
Lateral pin placement
Device: Lateral pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
Laterally-placed (side of the leg) femoral external fixator pind
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
| Milestone | 1 Anterior | 2 Lateral |
|---|---|---|
| Started | 15 | 20 |
| Completed | 5 | 9 |
| Not completed | 10 | 11 |
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
| Nm | 1-anterior Pin Placement | 2-lateral Pin Placement |
|---|---|---|
| Quadriceps Strength | 35.9 ± 10.7 | 39.6 ± 17.7 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Anterior | — | 2/5 (40%) | 0/5 (0%) |
| 2 Lateral | — | 3/9 (33.3%) | 0/9 (0%) |
| Event | 1 Anterior | 2 Lateral |
|---|---|---|
| deathInjury, poisoning and procedural complications | 1/5 | 2/9 |
| arthrofibrosisMusculoskeletal and connective tissue disorders | 1/5 | 0/9 |
| infectionInfections and infestations | 0/5 | 1/9 |
initially based on power analysis for anticipated quad strength data, final numbers based on those completing study in each group
| Age, Categorical(Participants) | 1-anterior Pin Placement | 2-lateral Pin Placement | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 9 | 14 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 1-anterior Pin Placement | 2-lateral Pin Placement | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 3 | 4 | 7 |
| Region of Enrollment(participants) | 1-anterior Pin Placement | 2-lateral Pin Placement | Total |
|---|---|---|---|
| United States | 5 | 9 | 14 |
Plan to share: No
No publications or documents are linked to this record.
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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