Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material

NCT02075853 | Completed

• 1 other identifier: 10-0531
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Cerebral Palsy; Pes Planus

Keywords

Cerebral palsy; Pes planus; Calcaneal lengthening

Outcome Measures

Primary Outcomes (1)

• Change in the amount of collapse

  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 of the graft.

  Pre-operatively (3-12 months), 6 weeks, 6 months, and 1 and 2 years post-operatively

Secondary Outcomes (1)

• Change in Plantar pressures

  Pre-operatively (3-12 months), then 1 and 2 years post-operatively

Other Outcomes (1)

• Change in Health related quality of life

  Pre-operativey (3-12 months), then at 6 months, 1 and 2 years post-operatively

Study Arms (2)

Bovine Xenograft

Patients in this group received a bovine xenograft in their Evans calcaneal lengthening procedure. Up until April 2014, patients were randomized into receiving the bovine graft or allograft. However, the bovine xenograft will no longer be manufactured, so no future patients will receive the bovine xenograft during the procedure.

Iliac Crest Allograft

Patients in this group received an iliac crest cadaver allograft (bicortical or tricortical) in their Evans calcaneal lengthening procedure. Up until April 2014, patients were randomized into receiving the bovine graft or allograft. However, the bovine xenograft will no longer be manufactured, so all future patients will receive the allograft during the procedure.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children receiving an Evans calcaneal lengthening procedure at Children's Hospital Colorado.

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Flatfoot

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Frank M Chang, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 3, 2014
• Study Start: September 1, 2010
• Primary Completion: November 27, 2018
• Study Completion: November 27, 2018
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

US (1)