Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material

Completed

Conditions studied: Cerebral Palsy, Pes Planus

In brief

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.

Key facts

Study ID

NCT02075853

Run by

University of Colorado, Denver

People needed

20

Starts

2010-09-01

Expected to finish

2018-11-27

Last updated by the study team

2021-04-30

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of spastic CP or similar neuromuscular disorder
• Surgical correction of pes planovalgus, through the Evans calcaneal lengthening
• Age 4-18 years old
• Gross Motor Function Classification System (GMFCS) 1-4
• Children who are ambulatory or non-ambulatory and able to stand for plantar pressures
• Children who have or will have a first metatarsal osteotomy at the foot

You may not qualify if…

• Concomitant bony surgical procedures at the foot either before or concomitantly with the Evans procedure
• Gross Motor Function Classification System (GMFCS) level of 5

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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