NCT00577226

Brief Summary

The objective of this study is to retrospectively and prospectively review patients who have undergone this technique looking at age of the patient, magnitude of the curve preoperatively, postoperatively and over time, diagnosis, pulmonary function, surgical procedures, complications, and spinal growth. The hypothesis is that Shilla growth permitting spinal instrumentation coupled with a surgical technique of aggressive correction of the apex of the scoliotic curve wil allow for natural growth of the spine in a guided fashion with a limited number of future surgeries required.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

10 years

First QC Date

December 18, 2007

Last Update Submit

May 4, 2016

Conditions

Scoliosis

Keywords

scoliosis, immature spine

Outcome Measures

Primary Outcomes (1)

  • Patients treated with Shilla procedure will undergo fewer surgeries than patients treated with traditional growing rod constructs.

    5 yrs

Secondary Outcomes (1)

  • Patients will have continued spinal growth

    5 yrs

Study Arms (1)

1 Shilla Technique

The patients whose data is observed are those who have undergone the shilla surgical technique.

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The patients whose data is observed are those who have undergone the shilla surgical technique.

You may qualify if:

  • between the ages of 1 yr and 10 yrs
  • have severe, progressive scoliosis unresponsive to bracing
  • have severe, progressive scoliosis who cannot tolerate bracing

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Childrens Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Richard E. McCarthy, M.D.

    University of Arkansas for Medical Sciences/Arkansas Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

April 1, 2005

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

US(1)