NCT01381198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

July 11, 2011

Status Verified

January 1, 2011

Enrollment Period

3.8 years

First QC Date

June 21, 2011

Last Update Submit

July 8, 2011

Conditions

Cerebral Palsy

Keywords

cerebral palsydistal rectus femoris transferstiff knee gait patterngait analysissingle event multilevel surgeryrandomized trialcrouch gait

Outcome Measures

Primary Outcomes (1)

  • Range of knee flexion in swing phase

    prior intervention (baseline) and 1 year post intervention

Secondary Outcomes (1)

  • Peak knee flexion in swing phase

    prior to intervention (basline) and 1 year post intervention

Study Arms (2)

Distal rectus femoris transfer

ACTIVE COMPARATOR

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

Procedure: Distal rectus femoris transfer

No distal rectus femoris transfer

NO INTERVENTION

Single-event multilevel surgery without distal rectus femoris transfer

Interventions

Distal rectus femoris transferPROCEDURE

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

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

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Department, University of Heidelberg

Heidelberg, 69118, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22425637DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 27, 2011

Study Start

June 1, 2007

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

July 11, 2011

Record last verified: 2011-01

Locations

DE(1)