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Gait chage after gartrocnemius & soloeus endoscopic release in patients with cerebral palsy

Status Approved

First Submitted Date

2017/06/10
Registered Date

2017/07/20
Last Updated Date

2017/06/29

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002382
Unique Protocol ID	HPIRB 2016-10-012-002
Public/Brief Title	Gait chage after gartrocnemius & soloeus endoscopic release in patients with cerebral palsy
Scientific Title	Gait chage after gartrocnemius & soloeus endoscopic release in patients with cerebral palsy
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	HPIRB 2016-10-012-002
Approval Date	2016-11-02
Institutional Review Board Name	Inje University HAeundae Paik Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Kunbo Park
Title	MD
Telephone	+82-2-2228-2195
Affiliation	Yonsei University
Address	50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
Contact Person for Public Queries
Name	Kunbo Park
Title	MD
Telephone	+82-2-2228-2195
Affiliation	Yonsei University
Address	50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea
Contact Person for Updating Information
Name	Kunbo Park
Title	MD
Telephone	+82-2-2228-2195
Affiliation	Yonsei University
Address	50-1 Yonsei-ro, Seodaemun-gu, Seoul, 03722, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2016-11-02 Actual
Target Number of Participant	30
Primary Completion Date	2017-01-31 , Actual
Study Completion Date	2017-02-10 , Actual
Name of Study	Inje University Haeundae Paik Hospital
Recruitment Status	Completed
Date of First Enrollment	2016-11-02 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Inje University Haeundae Paik Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Inje University Haeundae Paik Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Several methods exist for lengthening of triceps surae for the correction of ankle equinus, such as tendo-achilles lengthening, gastrocsoleus recession, and intramuscular lengthening. Gastrocsoleus recession results in greater muscle lengthening than does intramuscular lengthening, and is also more stable than tendo-achilles lengthening in terms of overcorrection. The only issue is the incision scar and the possibility of sural nerve injury. Endoscopic gastrocnemius recession yields a smaller incision and is associated with lower prevalence of nerve injury. The small incision is also important in single-event multi-level surgery in patients with cerebral palsy (CP). However, the optimal lengthening is more important because of crouch gait after overcorrection or re-operation for the recurrence of equinus after under correction in CP. Although short-term evaluations after endoscopic gastrocnemius-soleus recession in patients with CP have been reported previously, to our knowledge, there have been no reports after long term follow-up gait analysis. Furthermore, there was no definite description about the lengthening method in terms of Baumann, Strayer, Vulpius, or Baker in the endoscopic recession technique. If the gait improvement and long-term follow-up outcome of endoscopic gastrocsoleus recession in patients with CP is comparable to that of open surgery, the endoscopic surgery would be better for patients who underwent a single-event multi-level surgery (SEMLS). Endoscopic transverse Vulpius surgery has been performed in our institute as a part of SEMLS for 5 years. The purpose of our study was to compare the surgical outcomes between open and endoscopic transverse Vulpius surgeries in terms of scar formation and gait improvement.

Study Summary Information

Lay Summary

Several methods exist for lengthening of triceps surae for the correction of ankle equinus, such as tendo-achilles lengthening, gastrocsoleus recession, and intramuscular lengthening. Gastrocsoleus recession results in greater muscle lengthening than does intramuscular lengthening, and is also more stable than tendo-achilles lengthening in terms of overcorrection. The only issue is the incision scar and the possibility of sural nerve injury. Endoscopic gastrocnemius recession yields a smaller incision and is associated with lower prevalence of nerve injury.
The small incision is also important in single-event multi-level surgery in patients with cerebral palsy (CP). However, the optimal lengthening is more important because of crouch gait after overcorrection or re-operation for the recurrence of equinus after under correction in CP. Although short-term evaluations after endoscopic gastrocnemius-soleus recession in patients with CP have been reported previously, to our knowledge, there have been no reports after long term follow-up gait analysis. Furthermore, there was no definite description about the lengthening method in terms of Baumann, Strayer, Vulpius, or Baker in the endoscopic recession technique.
If the gait improvement and long-term follow-up outcome of endoscopic gastrocsoleus recession in patients with CP is comparable to that of open surgery, the endoscopic surgery would be better for patients who underwent a single-event multi-level surgery (SEMLS). Endoscopic transverse Vulpius surgery has been performed in our institute as a part of SEMLS for 5 years. The purpose of our study was to compare the surgical outcomes between open and endoscopic transverse Vulpius surgeries in terms of scar formation and gait improvement.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Retrospective
Target Number of Participant	30
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Cerebral palsy patients who had undergone endoscopic transverse Vulpius surgery
Cohort/ Group 1	Cohort/Group Description Scar, 3-dimensional gait analysis and ankle range of motion in Cerebral palsy patients who had undergone endoscopic transverse Vulpius surgery
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Cerebral palsy patients who had undergone endoscopic transverse Vulpius surgery
Sampling Method	Medical record review and recruit non-probabilistic all Cerebral palsy patients who had undergone endoscopic transverse Vulpius surgery
Condition(s)/Problem(s)	* (G00-G99)Diseases of the nervous system (G80.9)Cerebral palsy, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 5Year~12Year
	Description spastic diplegia, independent walker, and more than 2 years of follow-up gait analysis
Exclusion Criteria	previous surgeries before the index operation, Botox injection within 6 months from the surgery, and surgery after skeletal maturation
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Improvement in Gait analysis
Timepoint	Postoperative 2 years
Primary Outcome(s) 2
Outcome	, Operation scar
Timepoint	Postoperative 2 years
Secondary Outcome(s) 1
Outcome	ankle dorsiflexion angle with knee flexion and extension
Timepoint	Postoperative 2 years

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2021. 11
Way of Sharing	Available on Request (kunbopark@gmail.com)

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