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

July 8, 2011 updated by: Heidelberg University

Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69118
        • Orthopaedic Department, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Range of knee flexion in swing phase
Time Frame: prior intervention (baseline) and 1 year post intervention
prior intervention (baseline) and 1 year post intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak knee flexion in swing phase
Time Frame: prior to intervention (basline) and 1 year post intervention
prior to intervention (basline) and 1 year post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2011

Last Update Submitted That Met QC Criteria

July 8, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RecRan271/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe