Cerebral PalsyRectusTransNCT01381198
Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia
A study testing Distal rectus femoris transfer in people with Cerebral Palsy, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Distal rectus femoris transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cerebral palsy
- spastic diplegia
- ambulatory
- stiff knee gait
Who cannot join
- relevant previous surgery at the legs
- Botulinum-toxin-injections 6 months prior surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Orthopaedic Department, University of Heidelberg
Heidelberg, 69118
About this study
Official title: Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial
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.
- Conditions
- Cerebral Palsy
- Being tested
- Distal rectus femoris transfer
- Keywords
- cerebral palsy, distal rectus femoris transfer, stiff knee gait pattern, gait analysis, single event multilevel surgery, randomized trial, crouch gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal rectus femoris transferProcedure or surgery
Also called rectus tendon transfer, rectus femoris transfer, rectus transposition
Transfer of the distal rectus femoris tendon to the semitendinosus tendon.
| Study group | Role | What they receive |
|---|---|---|
| Distal rectus femoris transfer | Active comparator | Single-event multilevel surgery with a concomitant distal rectus femoris transfer Receives: Procedure: Distal rectus femoris transfer |
| No distal rectus femoris transfer | No intervention | Single-event multilevel surgery without distal rectus femoris transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of knee flexion in swing phase
Measured: prior intervention (baseline) and 1 year post intervention
Secondary outcomes (1)
Peak knee flexion in swing phase
Measured: prior to intervention (basline) and 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2007
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381198
- Sponsor's protocol ID
- RecRan271/2006
- Acronym
- RectusTrans
- Status last verified
- Jan 2011
- First submitted
- 21 Jun 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01381198
- Acronym / sponsor ID
- RectusTrans / RecRan271/2006
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, distal rectus femoris transfer, stiff knee gait pattern, gait analysis, single event multilevel surgery, randomized trial, crouch gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal rectus femoris transfer | Active comparator | Procedure: Distal rectus femoris transferSingle-event multilevel surgery with a concomitant distal rectus femoris transfer |
| No distal rectus femoris transfer | No intervention | –Single-event multilevel surgery without distal rectus femoris transfer |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- cerebral palsy
- spastic diplegia
- ambulatory
- stiff knee gait
Key exclusion criteria (2 listed)
- relevant previous surgery at the legs
- Botulinum-toxin-injections 6 months prior surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal rectus femoris transferAlso: rectus tendon transfer, rectus femoris transfer, rectus transpositionTransfer of the distal rectus femoris tendon to the semitendinosus tendon. | Procedure or surgery | Distal rectus femoris transfer |
Primary outcome
Range of knee flexion in swing phase
Time frame: prior intervention (baseline) and 1 year post intervention
1 secondary outcome
Peak knee flexion in swing phase
Time frame: prior to intervention (basline) and 1 year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
- Derived from this study: PubMed 22425637Dreher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal rectus femoris transfer in people with Cerebral Palsy, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of knee flexion in swing phase (time frame: prior intervention (baseline) and 1 year post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.