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

Heidelberg University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Procedure: Distal rectus femoris transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT01381198

RecRan271/2006

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Distal rectus femoris transfer

Active Comparator group

Description:

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

Treatment:

Procedure: Distal rectus femoris transfer

No distal rectus femoris transfer

No Intervention group

Description:

Single-event multilevel surgery without distal rectus femoris transfer