Comparison of Two Surgical Techniques to Treat Knock Knees in Children

• Sponsor: Aarhus University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01641354
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Duration (Months): 49
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Knock knees or genu valgus necessitates in some children corrective surgery with partial closure of the growth plate at level of the knee.

Condition or Disease	Intervention/Treatment	Phase
Genu Valgus	Procedure: Hemiepiphysiodesis	N/A

Detailed Description

Background: Genu valgus is a condition with malalignment of the lower extremity. Surgery may be indicated in severe cases and reversible hemiepiphysiodesis is often the treatment of choice in growing children. Partial closure can be obtained by stapling technique or with a new treatment called tension band plating.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Reversible Hemiepiphysiodesis in Children - Stapling Versus Eight Plate
• Study Start Date: May 1, 2009
• Anticipated Primary Completion Date: Jul 1, 2012
• Anticipated Study Completion Date: Jun 1, 2013

Outcome Measures

Primary Outcome Measures

1. Treatment time [up to 3 years]

Secondary Outcome Measures

1. Pain score post operatively [up to 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• genu valgus

• remaining growth

Exclusion Criteria:

• systemic disease

• unilateral disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus		Denmark	8000

Sponsors and Collaborators

• Aarhus University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin Gottliebsen, PhD-student, Aarhus University Hospital
• ClinicalTrials.gov Identifier: NCT01641354
• Other Study ID Numbers: M-20080179; J.nr. 2009-41-3248
• First Posted: Jul 16, 2012
• Last Update Posted: Jul 16, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Martin Gottliebsen, PhD-student, Aarhus University Hospital: Hemiepiphysiodesis
• Additional relevant MeSH terms: Genu Valgum

Study Results

No Results Posted as of Jul 16, 2012