search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Muscle fatty degeneration in brachial plexus injuries.


- candidate number8473
- NTR NumberNTR2524
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-sep-2010
- Secondary IDsP10.063 / 95100105 ; MEC LUMC / ZonMW
- Public TitleMuscle fatty degeneration in brachial plexus injuries.
- Scientific TitleQuantification of muscular fatty degeneration in brachial pexus injury patients.
- ACRONYMMuscular fatty degeneration
- hypothesisThe purpose of this study is:
1. To develop a method to quantify muscular fat content in brachial plexus injury patients;
2. To investigate whether muscular fat content is more in the affected arm compared to the contra lateral arm in BPI patients;
3. To evaluate differences in muscular fat content between patient groups with insufficient recovery and with sufficient recovery of muscle function.
- Healt Condition(s) or Problem(s) studiedBrachial plexus injury
- Inclusion criteria1. Brachial plexus injury patients with insufficient recovery of the musculus biceps brachii (MRC 0-3) will be included in group 1 and with a sufficient recovery (MRC 4) will be included in group 2;
2. Minimum 2 years after trauma or nerve surgery;
3. More then 18 years old.
- Exclusion criteria1. Bilateral brachial plexus injury;
2. Not 3 tesla MRI eligible due to any reason;
3. Not eligible to give informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-sep-2010
- planned closingdate1-jul-2011
- Target number of participants20
- Interventions3 Tesla MRI of both upper arms.
- Primary outcomePercentage of muscle fattening of the m. biceps brachii.
- Secondary outcome1. Elbow flexion stength in Newton and MRC classification;
2. Goutallier score of muscle fatty degeneration;
3. Quality of life questionnaires.
- TimepointsOne timepoint at which MRI, physical examination and questionnaires will be performed.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. MSc. B.J. Duijnisveld
- CONTACT for SCIENTIFIC QUERIESMD. MSc. B.J. Duijnisveld
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryA brachial plexus injury is the most severe nerve injury of the extremities. In spite of natural recovery, the majority of these patients have residual muscle weakness and need nerve and/or secondary surgery to improve the utility of their arm. Long-term denervation results in muscle atrophy, fatty degeneration and interstitial fibrosis of the muscle. Quantitative tools which assess muscular fat content could improve insight in the extent of muscle degeneration and could facilitate a better treatment strategy.
- Main changes (audit trail)
- RECORD20-sep-2010 - 3-okt-2010


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl