Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000536460
Ethics application status
Approved
Date submitted
14/10/2007
Date registered
19/10/2007
Date last updated
19/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A new patellar misalignment measurement device: Dismetrometro
Scientific title
A new patellar misalignment measurement device: Dismetrometro
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disfunctional patellar misalignment 2460 0
Condition category
Condition code
Musculoskeletal 2558 2558 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Asymmetries in the lower limbs are easy to see at patellar level as a longitudinal
misalignment of the patellar borders. A statistical measurement of this misalignment has never been carried
out. In this study, we have used a new instrument, invented by us, to measure the longitudinal misalignment
of the upper borders of the patella. This instrument has been called "Dismetrometro". The name "Dismetrometro" comes from the term dysmetria. The Dismetrometro is an instrument for measuring misalignments. Using our instrument in this study, we carried out the statistical measurement of
the misalignment of the patellar borders. During our study we assessed 100 healthy individuals using the Dismetrometro device. Each individual had a negative anamnesis for orthopaedic pathologies of the lower limbs. Data collection was been completed in one month.
Intervention code [1] 2186 0
Not applicable
Comparator / control treatment
Three different operators (OP1, OP2, OP3) measure the same sample of subjects three times (first session). This procedure is repeated after one week (second session). The measurements collected in the dataset are in millimetres to one decimal point.
The patellar superior border misalignment measurements are performed by three different operators for all subjects.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3465 0
Evaluate the efficiency, efficacy of measurements carried out with this new type of calliper: Dismetrometro
Timepoint [1] 3465 0
The measurement trial consisted of two following sessions. The second session was carried out a week apart. In each session three different operators have measured the misalignment in every subjects.
Secondary outcome [1] 5781 0
Evaluate the reproducibility of measurements carried out with this new type of calliper: Dismetrometro
Timepoint [1] 5781 0
In order to verify the repeatability and reproducibility of the measurements over time, the same session procedure was performed after seven days.

Eligibility
Key inclusion criteria
healthy subject,with a negative anamnesis for muscular or bone-relevant trauma in the last 3 years
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
congenital malformation and other musculoskeletal or neurologically-known pathologies

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/1997
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 624 0
Italy
State/province [1] 624 0

Funding & Sponsors
Funding source category [1] 2704 0
Charities/Societies/Foundations
Name [1] 2704 0
Istituto Rinaldi Fontani
Country [1] 2704 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Istituto Rinaldi Fontani
Address
Via Nazionale 23, 50123 Firenze
Country
Italy
Secondary sponsor category [1] 2448 0
Charities/Societies/Foundations
Name [1] 2448 0
Societa di Ottimizzazione Neuro Psico Fisica e CRM Terapia
Address [1] 2448 0
Via Nazionale 23, 50123 Firenze
Country [1] 2448 0
Italy

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The Dismetrometro is an instrument for measuring misalignments. Using this instrument, we carried out the statistical measurement of the misalignment of the patellar upper borders.
During our study we assessed 100 healthy individuals using the Dismetrometro device. Each individual had a negative anamnesis for orthopaedic pathologies of the lower limbs. The average measurement of the
vertical distance between the two sides was 6.9 +/- 0.5 mm (S.D). This measurement is irrespective of gender and age, repeatable over a period of time and reproducible between different operators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28115 0
Address 28115 0
Country 28115 0
Phone 28115 0
Fax 28115 0
Email 28115 0
Contact person for public queries
Name 11272 0
Vania Fontani M.D.
Address 11272 0
Via Nazionale 23, 50123 Firenze
Country 11272 0
Italy
Phone 11272 0
+39 055 290307
Fax 11272 0
Email 11272 0
[email protected]
Contact person for scientific queries
Name 2200 0
Salvatore Rinaldi M.D.
Address 2200 0
Via Nazionale 23, 50123 Firenze
Country 2200 0
Italy
Phone 2200 0
+39 055 290307
Fax 2200 0
Email 2200 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.