Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02075853 |
| Other study ID # |
10-0531 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2010 |
| Est. completion date |
November 27, 2018 |
Study information
| Verified date |
April 2021 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Primary Outcome Measures:
1. 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 radiographs, the amount of collapse will be determined by
measuring the distance from one heme clip to the other. Changes in the distance between
the clips indicate collapse of the graft.
2. Radiographic measurements of weight bearing feet of the bovine xenograft group and iliac
crest allograft group (tricortical and bicortical), pre-operatively and
post-operatively.
1. Lateral Radiographs: Talocalcaneal angle, Talo first metatarsal angle, Talo
horizontal angle, and Calcaneal pitch
2. Anterior-Posterior Radiographs: Talocalcaneal angle, Talo first metatarsal angle,
and Talonavicular coverage
3. Comparison of ligamentous laxity between the two grafting material groups, as measured
by the Beighton measurements at patient's pre-operative orthopaedic clinical
appointment.
Secondary Outcome Measures:
1. Plantar pressures values of interest are of six segments: medial heel, lateral heel,
medial midfoot, lateral midfoot, first metatarsal and second metatarsal. The center of
pressure index, total contact area, mean pressure, peak pressure, and pressure time intervals
will also be collected and assessed to determine pressure distribution of the foot.
Tertiary Outcome Measures:
1. Health related quality of life assessments between the two groups, pre-operative and
post-operative as measured by the Pediatric Orthopaedic Data Collection Instrument (PODCI)
questionnaire.
