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CompletedNCT01381198RectusTransUpdated Jul 11, 2011

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

An interventional study of Distal rectus femoris transfer in Cerebral Palsy, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2011-07-11.

Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • cerebral palsy
  • distal rectus femoris transfer
  • stiff knee gait pattern
  • gait analysis
  • single event multilevel surgery
  • randomized trial
  • crouch gait
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 36 is close to the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Heidelberg University is the lead sponsor of 279 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • relevant previous surgery at the legs
  • Botulinum-toxin-injections 6 months prior surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    Distal rectus femoris transfer

    Single-event multilevel surgery with a concomitant distal rectus femoris transfer

    Procedure: Distal rectus femoris transfer

  • No intervention
    No distal rectus femoris transfer

    Single-event multilevel surgery without distal rectus femoris transfer

Interventions

  • ProcedureDistal rectus femoris transfer

    Transfer of the distal rectus femoris tendon to the semitendinosus tendon.

    Also known as: rectus tendon transfer, rectus femoris transfer, rectus transposition

06

What researchers measure

Primary outcomes

  1. Range of knee flexion in swing phase

    Time frame: prior intervention (baseline) and 1 year post intervention

Secondary outcomes

  1. Peak knee flexion in swing phase

    Time frame: prior to intervention (basline) and 1 year post intervention

07

Study locations

1 site
  • Orthopaedic Department, University of Heidelberg
    Heidelberg, 69118, Germany
08

References and documents

Publications

  • Dreher T, Gotze M, Wolf SI, Hagmann S, Heitzmann D, Gantz S, Braatz F. Distal rectus femoris transfer as part of multilevel surgery in children with spastic diplegia--a randomized clinical trial. Gait Posture. 2012 Jun;36(2):212-8. doi: 10.1016/j.gaitpost.2012.02.017. Epub 2012 Mar 15. PubMed 22425637 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01381198
Lead sponsor
Heidelberg University
First posted
Jun 27, 2011
Start date
Jun 2007
Primary completion
Apr 2011
Completion
May 2011
Last update
Jul 11, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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