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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01381198
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Cerebral Palsy Procedure: Distal rectus femoris transfer

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2007
Primary Completion Date : April 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Range of knee flexion in swing phase [ Time Frame: prior intervention (baseline) and 1 year post intervention ]

Secondary Outcome Measures :
  1. Peak knee flexion in swing phase [ Time Frame: prior to intervention (basline) and 1 year post intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01381198


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

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
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: July 11, 2011
Last Verified: January 2011

Keywords provided by Heidelberg University:
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