Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia (RectusTrans)
This study has been completed.
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01381198
First received: June 21, 2011
Last updated: July 8, 2011
Last verified: January 2011
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 21, 2011 |
| Last Updated Date | July 8, 2011 |
| Start Date ICMJE | June 2007 |
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Range of knee flexion in swing phase [ Time Frame: prior intervention (baseline) and 1 year post intervention ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01381198 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Peak knee flexion in swing phase [ Time Frame: prior to intervention (basline) and 1 year post intervention ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia |
| Official Title ICMJE | Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Condition ICMJE | Cerebral Palsy |
| Intervention ICMJE | Procedure: Distal rectus femoris transfer
Transfer of the distal rectus femoris tendon to the semitendinosus tendon.
Other Names:
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| Study Arm (s) |
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| Publications * | Dreher T, Götze 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. Epub 2012 Mar 15. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 36 |
| Completion Date | May 2011 |
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 6 Years to 16 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Germany |
| Administrative Information | |
| NCT Number ICMJE | NCT01381198 |
| Other Study ID Numbers ICMJE | RecRan271/2006 |
| Has Data Monitoring Committee | No |
| Responsible Party | Dr. Thomas Dreher, MD, Orthopaedic Department, Universitiy of Heidelberg |
| Study Sponsor ICMJE | University of Heidelberg |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | University of Heidelberg |
| Verification Date | January 2011 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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