Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000631808
Ethics application status
Approved
Date submitted
12/06/2012
Date registered
13/06/2012
Date last updated
13/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Outcome of Juvenile Anterior Cruciate Ligament (ACL) reconstruction with Live Donor Allograft
Scientific title
Outcome of Juvenile Anterior Cruciate Ligament (ACL) reconstruction with Live Donor Allograft
Secondary ID [1] 280654 0
nil
Universal Trial Number (UTN)
U1111-1131-7045
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Reconstruction 286675 0
Condition category
Condition code
Surgery 286976 286976 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this research is to assess the 2 year clinical outcome of live donor hamstring tendon allograft in juvenile ACL reconstruction. Assessment will include knee stability, subjective outcomes, return to sport and reinjury at 1 and 2 years after surgery with standardised, reliable and validated assessment tools.
Intervention code [1] 285059 0
Not applicable
Comparator / control treatment
Nil control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287310 0
Clinical and subjective outcome as assessed by the International Knee
Documentation Committee (IKDC) Evaluation, KT1000 arthrometer, Lysholm
Knee Score, effusion, and kneeling pain
Timepoint [1] 287310 0
2 years
Secondary outcome [1] 297880 0
Skeletal alignment at maturity assessed via radiographs and Tanner scores
Timepoint [1] 297880 0
Review peformed at 12 and 24 months

Eligibility
Key inclusion criteria
1. Patients age 16 years or less at time of surgery
2. Patients undergoing ACL reconstruction with the use of live donor hamstring tendon graft by Dr Pinczewski or Dr Roe
3. Surgery to be performed at the Mater Hospital, Sydney
4. Patients willing to participate in a research program
5. Patients willing and able to attend Mater clinic for assessments
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unwilling or unable to attend Mater clinic for assessments

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285423 0
Charities/Societies/Foundations
Name [1] 285423 0
Friends of The Mater Foundation
Country [1] 285423 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Friends of The Mater Foundation
Address
PO Box 958 North Sydney NSW 2059
Country
Australia
Secondary sponsor category [1] 284275 0
None
Name [1] 284275 0
Address [1] 284275 0
Country [1] 284275 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287433 0
St Vincents HREC
Ethics committee address [1] 287433 0
Research Office
Level 6, de Lacy Building
St Vincent's Hospital
Darlinghurst NSW 2010
Ethics committee country [1] 287433 0
Australia
Date submitted for ethics approval [1] 287433 0
19/04/2012
Approval date [1] 287433 0
03/05/2012
Ethics approval number [1] 287433 0
1/12/0073

Summary
Brief summary
This study will prospectively follow group of up to 100 patients who undergo ACL reconstruction under the age of 17 years with the use of a live donor allograft.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34299 0
Address 34299 0
Country 34299 0
Phone 34299 0
Fax 34299 0
Email 34299 0
Contact person for public queries
Name 17546 0
Lucy Salmon
Address 17546 0
NSOSMC
The Mater Clinic
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country 17546 0
Australia
Phone 17546 0
+61294375999
Fax 17546 0
+61294379595
Email 17546 0
[email protected]
Contact person for scientific queries
Name 8474 0
Lucy Salmon
Address 8474 0
NSOSMC
The Mater Clinic
Suite 2, 3 Gillies St
Wollstonecraft NSW 2065
Country 8474 0
Australia
Phone 8474 0
+61294375999
Fax 8474 0
+61294379595
Email 8474 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.