coxarthrosis MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: DYSPORT*SC IM 2FL 500U
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BOTULINUM TOXIN TYPE A
CAS Number: 93384-43-1
Concentration unit: U/ml unit(s)/millilitre
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA S. MARIA DELLA MISERICORDIA DI UDINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients must fulfil the following criteria: Subjects with primary or secondary symptomatic painful coxarthrosis, defined by radiographic signs (Rx or MRI or TC Scan) (see Table 1) and quantitative measurement of joint space - Age between 18 - 80 years - Written Voluntary Consent of the subject - Impossibility of surgical treatment or elective surgery after six month to orthopaedic visit - HHS > 20 (because in the previous study baseline HHS was 40 +/- 21) VAS > 4 (minimal value defined as “significant pain”) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: - Documented systemic allergy - Pregnancy - Women who plan a pregnancy within six months of the treatment - Previous treatment with BoNT/A, whatever the indication. - Physiotherapy or articular injections with analgesic, hyaluronic acid or corticosteroids in the previous 60 days - History of relevant central or peripheral neurological diseases. -Patients subjected to a previous THA (total hip arthroplasty) - In the opinion of the investigator the subject is unable and/or unwilling to comply fully with the protocol and the study instructions - Apparent remission of coxarthrosis within 3 months- Subject who in the previous 4 weeks have made changes on analgesic oral therapy .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy variables will be the Harris Hip Score (HHS) at week 4.;Secondary Objective: Secondary efficacy variables will be considered the following : the Harris Hip Score (HHS) at week 2 and 12; the Subjective reporting of pain intensity (by a Visual Analogue Scale VAS) at week 2, 4, 12; the MRC scale (Scale to evaluate the muscular strength) and the SF-36 Quality of Life questionnaire. at week 2, 4, 12.;Primary end point(s): The primary efficacy variables will be the Harris Hip Score (HHS) at week 4.;Timepoint(s) of evaluation of this end point: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 2, 4, 12 weeks;Secondary end point(s): Secondary efficacy variables will be considered the following : the Harris Hip Score (HHS) at week 2 and 12; the Subjective reporting of pain intensity (by a Visual Analogue Scale VAS) at week 2, 4, 12; the MRC scale (Scale to evaluate the muscular strength) and the SF-36 Quality of Life questionnaire. at week 2, 4, 12. | — |
Countries
Italy
Contacts
Public ContactSOC Neurologia
Az. Ospedaliero-Universitaria Udine
Outcome results
None listed