Stapling Versus 8plate for Correction of Genu Valgus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01528553
First received: January 20, 2012
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Deformity
Genu Valgus
Device: 8plate
Device: Staples (Richards, Smith & Nephew)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Stapling Versus 8plate for Correction of Genu Valgus. A Randomised Clinical Study

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Treatment time [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
    Will be followed with repeated clinical examinations until correction of deformity.


Secondary Outcome Measures:
  • Radiological correction [ Time Frame: up to 104 weeks ] [ Designated as safety issue: No ]
    After correction of deformity.


Enrollment: 20
Study Start Date: August 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Staples
Old implant type
Device: Staples (Richards, Smith & Nephew)
Staples (3 on each side)
Other Name: Richards staples, Smith & Nephew
Active Comparator: 8plate
New implant type
Device: 8plate
12 mm or 16 mm plate. 24 mm or 36 mm screw
Other Name: 8plate system

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.

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic genu valgus
  • At least one year of remaining growth

Exclusion Criteria:

  • Unilateral conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528553

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Bjarne Møller-Madsen, Professor Aarhus University Hospital
  More Information

Additional Information:
Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01528553     History of Changes
Other Study ID Numbers: VEK 20080179
Study First Received: January 20, 2012
Last Updated: February 3, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
genu valgus
lower limb
paediatric
epiphysiodesis

Additional relevant MeSH terms:
Genu Valgum
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014