Stapling Versus 8plate for Correction of Genu Valgus | NCT01528553

Studies
Stapling Versus 8plate for Correction of Genu Valgus

NCT01528553

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Feb 8, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Deformity
Genu Valgus

Interventions

8plate
Staples (Richards, Smith & Nephew)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Jan 20, 2012

First Submission Date that Met QC Criteria

Feb 3, 2012

First Posted Date

Feb 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2012

Last Update Posted Date

Feb 8, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In children with excessive knock knees it may be necessary to use guided growth (small surgical procedure) so the child outgrows the condition before maturity. A new implant is on the market and the investigators compare this implant (8plate) with the old technique (staples) in a randomised setup.

The hypothesis is that the 8plate provides a faster correction rate and that this treatment is superior to stapling.

Detailed Description

Correcting angulating deformities of the lower limb is a subject of major interest in paediatric orthopaedics. Epiphysiodesis is the technique by which unilateral bone growth is stopped. Traditionally this has been performed with staple technique. The 8-plate technique is new and advocated because it is believed to reduce the risk of premature closure of the growth plate compared to stapling. The benefit of the 8-plate technique has not yet been proven in experimental or randomised clinical studies.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Staples	Active Comparator	Old implant type	Device: Staples (Richards, Smith & Nephew)
8plate	Active Comparator	New implant type	Device: 8plate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
8plate	Device	12 mm or 16 mm plate. 24 mm or 36 mm screw	8plate	8plate system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment time	Will be followed with repeated clinical examinations until correction of deformity.	up to 104 weeks

Secondary Outcomes

Measure	Description	Time Frame
Radiological correction	After correction of deformity.	up to 104 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Idiopathic genu valgus
At least one year of remaining growth

Exclusion Criteria:

Unilateral conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjarne Møller-Madsen, Professor	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus		8000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17414005	Background	Stevens PM. Guided growth for angular correction: a preliminary series using a tension band plate. J Pediatr Orthop. 2007 Apr-May;27(3):253-9. doi: 10.1097/BPO.0b013e31803433a1.
21983939	Background	Jelinek EM, Bittersohl B, Martiny F, Scharfstadt A, Krauspe R, Westhoff B. The 8-plate versus physeal stapling for temporary hemiepiphyseodesis correcting genu valgum and genu varum: a retrospective analysis of thirty five patients. Int Orthop. 2012 Mar;36(3):599-605. doi: 10.1007/s00264-011-1369-5. Epub 2011 Oct 9.

ID	Term
D000013	Congenital Abnormalities
D056304	Genu Valgum

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies