Efficacy and safety of early intramuscular botulinum toxin injections in the prevention of shoulder deformity in infants with obstetric brachial plexus palsy: a randomized double-blind multicenter controlled trial.

Conditions

Obstetrical Brachial Plexus Palsy

Brief summary

Evolution of the percentage of posterior migration of the humeral head measured in MRI on an axial section, between 11 months (before botulinum toxin injection at 12 months) and 18 months (6 months after injection) of age.

Detailed description

2D glenoid evolution measured in MRI on an axial slice (1st secondary objective), Evolution of the glenoid version and three-dimensional humeral head migration on MRI (1st secondary objective), Changes in passive joint amplitudes (2nd secondary objective), Evolution of the AMS (Active Movement Scale) (2nd secondary objective), Progression of mini-AHA (mini-Assistive Hand Assessment) score (2nd secondary objective), Assessment of the number of non-serious and serious adverse events (3rd secondary objective), Assessment of trophicity (muscle volume) and fatty infiltration of injected muscles (supraspinatus, infraspinatus and lesser round, subscapularis, greater round, pectoralis major, deltoid, greater dorsalis) (4th secondary objective)., Surgical management of the children included in each group will be recorded post-study during medical follow-up (routine clinical practice) up to the 10th year of life after the blind has been lifted (5th secondary objective).

Related papers

No related papers found yet.

Interventions

DRUGSODIUM CHLORIDE

DRUGBOTOX 100 Unità Allergan Polvere per soluzione iniettabile

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Evolution of the percentage of posterior migration of the humeral head measured in MRI on an axial section, between 11 months (before botulinum toxin injection at 12 months) and 18 months (6 months after injection) of age.	—

Secondary

Measure	Time frame
2D glenoid evolution measured in MRI on an axial slice (1st secondary objective), Evolution of the glenoid version and three-dimensional humeral head migration on MRI (1st secondary objective), Changes in passive joint amplitudes (2nd secondary objective), Evolution of the AMS (Active Movement Scale) (2nd secondary objective), Progression of mini-AHA (mini-Assistive Hand Assessment) score (2nd secondary objective), Assessment of the number of non-serious and serious adverse events (3rd secondary objective), Assessment of trophicity (muscle volume) and fatty infiltration of injected muscles (supraspinatus, infraspinatus and lesser round, subscapularis, greater round, pectoralis major, deltoid, greater dorsalis) (4th secondary objective)., Surgical management of the children included in each group will be recorded post-study during medical follow-up (routine clinical practice) up to the 10th year of life after the blind has been lifted (5th secondary objective).	—

Measure

Time frame

2D glenoid evolution measured in MRI on an axial slice (1st secondary objective), Evolution of the glenoid version and three-dimensional humeral head migration on MRI (1st secondary objective), Changes in passive joint amplitudes (2nd secondary objective), Evolution of the AMS (Active Movement Scale) (2nd secondary objective), Progression of mini-AHA (mini-Assistive Hand Assessment) score (2nd secondary objective), Assessment of the number of non-serious and serious adverse events (3rd secondary objective), Assessment of trophicity (muscle volume) and fatty infiltration of injected muscles (supraspinatus, infraspinatus and lesser round, subscapularis, greater round, pectoralis major, deltoid, greater dorsalis) (4th secondary objective)., Surgical management of the children included in each group will be recorded post-study during medical follow-up (routine clinical practice) up to the 10th year of life after the blind has been lifted (5th secondary objective).

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Countries

France

Outcome results

None listed