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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: Completed study of Cerebral Palsy and Pes Planus, sponsored by University of Colorado, Denver.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Measurement on radiographs of distance between heme clips located in calcaneous bone of the foot. Within the patient's own calcaneous bone, a heme clip will be placed on each side of the osteotomy. From post-operative radiographs, the amount of collapse will be determined by measuring the distance from one heme clip to the other. Post-operative changes in the distance between the clips from the first radiograph after surgery (used as a baseline, usually 6 weeks after surgery) indicate collapse o

Study Locations (1)

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2010-09
Est. Completion 2018-11-27
University of Colorado, Denver

1,283 total trials

What the finished NCT02075853 record still lists

NCT02075853 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (91% lower).

The record links to 2 conditions, with Cerebral Palsy appearing as the primary indexed condition, and to 0 interventions.

NCT02075853 reports a single indexed study location in 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.

Similar trials for Cerebral Palsy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02075853's enrollment target sits among peer trials

20 67th of 91 higher than 19 of 91 other Cerebral Palsy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cerebral Palsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02075853, the US trial registry maintained by the National Library of Medicine. NCT02075853 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.