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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Distal rectus femoris transfer

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, distal rectus femoris transfer, stiff knee gait pattern, gait analysis, single event multilevel surgery, randomized trial, crouch gait

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orthopaedic Department, University of Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Distal rectus femoris transfer

No distal rectus femoris transfer

Arm Description

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

Single-event multilevel surgery without distal rectus femoris transfer

Outcomes

Primary Outcome Measures

Range of knee flexion in swing phase

Secondary Outcome Measures

Peak knee flexion in swing phase

Full Information

NCT ID

NCT01381198

First Posted

June 21, 2011

Last Updated

July 8, 2011

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT01381198

Brief Title

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

Acronym

RectusTrans

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Distal rectus femoris transfer

Arm Type

Active Comparator

Arm Description

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

Arm Title

No distal rectus femoris transfer

Arm Type

No Intervention

Arm Description

Single-event multilevel surgery without distal rectus femoris transfer

Intervention Type

Procedure

Intervention Name(s)

Distal rectus femoris transfer

Other Intervention Name(s)

rectus tendon transfer, rectus femoris transfer, rectus transposition

Intervention Description

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

Primary Outcome Measure Information:

Title

Range of knee flexion in swing phase

Time Frame

prior intervention (baseline) and 1 year post intervention

Secondary Outcome Measure Information:

Title

Peak knee flexion in swing phase

Time Frame

prior to intervention (basline) and 1 year post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Orthopaedic Department, University of Heidelberg

City

Heidelberg

ZIP/Postal Code

69118

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22425637

Citation

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.

Results Reference

derived

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

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