Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000416594
Ethics application status
Not yet submitted
Date submitted
11/06/2006
Date registered
25/09/2006
Date last updated
25/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Incision Orientation and Risk of Injury to the Infrapatellar Branch of the Saphenous Nerve in Anterior Cruciate Ligament Reconstruction Surgery.
Scientific title
Incision Orientation and Risk of Injury to the Infrapatellar Branch of the Saphenous Nerve in Anterior Cruciate Ligament Reconstruction Surgery.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ACL reconstruction surgery and IPBSN injuy 1385 0
Condition category
Condition code
Musculoskeletal 1477 1477 0 0
Other injuries and accidents
Musculoskeletal 1478 1478 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hamstring harvest incision orientation of either oblique or horizontal in elective ACL reconstruction.

The surgery takes approximately 1- 2 hours and surgery is performed at a variable time after injury depepnding on indication.
Intervention code [1] 1136 0
Treatment: Surgery
Comparator / control treatment
Hamstring harvest incision orientation of vertical in elective ACL reconstruction.
Control group
Active

Outcomes
Primary outcome [1] 2050 0
Rate of injury to infrapatellar branch of saphenous nerve
Timepoint [1] 2050 0
Measured at 3 months
Secondary outcome [1] 3530 0
Patient Satisfaction
Timepoint [1] 3530 0
At 3 months
Secondary outcome [2] 3531 0
Cosmesis
Timepoint [2] 3531 0
At 3 months

Eligibility
Key inclusion criteria
Consecutive patients for elective ACL surgery without preexisting neurological deficit or symtoms in single ligament injured knees.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Knees requiring open meniscal repair technique will also be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table with block system for close to equal numbers. block size based on randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1617 0
Government body
Name [1] 1617 0
Queensland health
Country [1] 1617 0
Australia
Primary sponsor type
Individual
Name
Dr Peter McEwen
Address
Country
Secondary sponsor category [1] 1418 0
None
Name [1] 1418 0
nil
Address [1] 1418 0
Country [1] 1418 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Injury to the Infrapatellar branch of the saphenous nerve (IPBSN) may result uncomfortable or even painful sensory changes to the skin over the front of the knee.

Anterior cruciate ligament (ACL) reconstruction in an established effective procedure in symptomatic instability. There are two main techniques for the surgery. A 4 strand hamstring graft is commonly performed in Australia.

The nerve or its branches run very closely to or through the site of incision for hamstring harvest or the main alternative procedure harvesting patellar ligament and bone.

Injury to the IPBSN or its branches is common in ACL surgery.

Anatomical dissection studies have recommended that oblique or horizontal incisons may result in a lower rate of nerve injury.

The current standard technique is a vertical incision.

There has been a clinical outcome study investigating obliquity of incision in patellar ligament grafts which demonstrated a relationship with nerve injury. There has not been an clinical outcome study investigating obliquity of incision and nerve injury in hamstring grafts.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36196 0
Address 36196 0
Country 36196 0
Phone 36196 0
Fax 36196 0
Email 36196 0
Contact person for public queries
Name 10325 0
Dr Sam Martin
Address 10325 0
Townsville Hospital
Kirwan
Townsville QLD 4814
Country 10325 0
Australia
Phone 10325 0
+61 7 47961111
Fax 10325 0
Email 10325 0
[email protected]
Contact person for scientific queries
Name 1253 0
Dr Peter Mcewen
Address 1253 0
Townsville Hospital
Kirwan
Townsville QLD 4814
Country 1253 0
Australia
Phone 1253 0
+61 7 47961111
Fax 1253 0
Email 1253 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.