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Study on reversible effect on muscle of the botulinica toxin on the prevention of the post-traumatic rigidity of elbow - TB2006

Study on reversible effect on muscle of the botulinica toxin on the prevention of the post-traumatic rigidity of elbow - TB2006

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000919-29-IT
Enrollment
Unknown
Registered
2007-09-11
Start date
2006-12-20
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

omero mono-Inter-sovra-sovraintercondiloidee fractures of distant them, fractures of capitello radial and fractures of olecrano with or without luxation MedDRA version: 9.1 Level: LLT Classification code 10028330 Term: Muscle rigidity

Interventions

Trade Name: BOTOX Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Botulinum toxin Concentration unit: IU international unit(s) Concentration type: equal Concentration numbe

Sponsors

ISTITUTI ORTOPEDICI RIZZOLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: They will come included patients with age comprised between 14 and 75 years, male sex and feminine without racial exclusion with omero mono-Inter-sovra-sovraintercondiloidee fractures it tos be distant them, fractures of capitello radial and fractures of olecrano with or without luxation. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Neuromuscular (serious myasthenia and amiotrofica lateral sclerosis), association with aminoglicosidi, spectinomicina and curaroderivati diseases. Paralysis of whichever degree of the tricipite muscle.

Design outcomes

Primary

MeasureTime frame
Main Objective: To estimate the effectiveness of the botulinica toxin type To in preventing the post-traumatic rigidity of elbow in the patients operates you of osteosintesi;Secondary Objective: noone;Primary end point(s): Passive and active motorio recovery—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026