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NCT02075853 · ClinicalTrials.gov registry record
Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material
A clinical trial of Cerebral Palsy and Pes Planus, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT02075853 is a study of Cerebral Palsy and Pes Planus that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02075853, a study of Cerebral Palsy and Pes Planus, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The Evans calcaneal lengthening is a common surgical correction used for children with spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials have been used for this procedure, but both types of grafting materials have associated limitations. Autologous grafting materials, which are harvested from the iliac crest at the time of surgery, are associated with high rates of prolonged donor site pain. There is limited bone available from the iliac crest. For this reason autologous bone grafts are not commonly used for the Evan's procedure. Cadaver allografting materials are variable in their mechanical and geometric properties. Recently, xenografting materials have been developed that have consistent mechanical properties and are available in a larger size that is formed to fit the individual patient intraoperatively. The purpose of this study is to evaluate the long term outcomes of the procedure with the different graft options. Another purpose is to compare the difference in surgical correction obtained with the cadaver allograft and the xenografting materials. This study will also observe and evaluate a wide range of outcome variables that encompass multiple levels of patient care, from clinical observation to parent and patient satisfaction, and compare these with the observed changes in the radiographic and plantar pressure parameters of the foot. This data will be evaluated pre to post surgery and for two years of follow-up time. The aim is to uncover the characteristics of collapse observed with the two different grafting materials.
Conditions Studied
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-09 |
| Est. Completion | 2018-11-27 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02075853
The ClinicalTrials.gov registry entry for NCT02075853 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (91% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 0 interventions.
NCT02075853 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT02075853 about?
NCT02075853 is a clinical study titled "Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material". The Evans calcaneal lengthening is a common surgical correction used for children with spastic cerebral palsy (CP) and painful flat feet. This procedure involves the insertion of a trapezoidal bone graft into the calcaneus bone. Both autograft and allografting materials have been used for this proce...
What is the current status of trial NCT02075853?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2010-09. Estimated completion is 2018-11-27.
What conditions does trial NCT02075853 study?
This clinical trial studies the following conditions: Cerebral Palsy, Pes Planus.
Who is sponsoring clinical trial NCT02075853?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02075853 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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