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Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia (RectusTrans)

This study has been completed.
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01381198
First received: June 21, 2011
Last updated: July 8, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the effects of an additional distal rectus femoris transfer carried out as a part of single-event multilevel surgery in children with spastic diplegic cerebral palsy.


Condition Intervention
Cerebral Palsy
 Procedure: Distal rectus femoris transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Range of knee flexion in swing phase [ Time Frame: prior intervention (baseline) and 1 year post intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak knee flexion in swing phase [ Time Frame: prior to intervention (basline) and 1 year post intervention ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2007
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Distal rectus femoris transfer
Single-event multilevel surgery with a concomitant distal rectus femoris transfer
 Procedure: Distal rectus femoris transfer
Transfer of the distal rectus femoris tendon to the semitendinosus tendon.
Other Names:
  • rectus tendon transfer
  • rectus femoris transfer
  • rectus transposition
No Intervention: No distal rectus femoris transfer
Single-event multilevel surgery without distal rectus femoris transfer

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cerebral palsy
  • spastic diplegia
  • ambulatory
  • stiff knee gait

Exclusion Criteria:

  • relevant previous surgery at the legs
  • Botulinum-toxin-injections 6 months prior surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381198

Locations
Germany
Orthopaedic Department, University of Heidelberg
Heidelberg, Germany, 69118
Sponsors and Collaborators
University of Heidelberg
  More Information

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Thomas Dreher, MD, Orthopaedic Department, Universitiy of Heidelberg
ClinicalTrials.gov Identifier: NCT01381198     History of Changes
Other Study ID Numbers: RecRan271/2006
Study First Received: June 21, 2011
Last Updated: July 8, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
cerebral palsy
distal rectus femoris transfer
stiff knee gait pattern
gait analysis
 single event multilevel surgery
randomized trial
crouch gait

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013