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Trial registered on ANZCTR
Registration number
ACTRN12618001454268
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
29/08/2018
Date last updated
29/08/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Anterior cruciate ligament reconstruction with the peroneous longus tendon
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Scientific title
Patient outcome following peroneus longus autograft anterior cruciate ligament reconstruction in patients with anterior cruciate ligament rupture
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Secondary ID [1]
295795
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Nil known
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Universal Trial Number (UTN)
U1111-1218-9213
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Trial acronym
PLA ACL reconstruction
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament rupture
309228
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Condition category
Condition code
Surgery
308101
308101
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0
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Surgical techniques
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Musculoskeletal
308213
308213
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Primary anterior cruciate ligament (ACL) reconstruction with a peroneus longus autograft. Instead of taking one of the hamstring tendons from behind the knee the peroneus longus tendon is taken from the outside of the ankle to make the new ACL. The whole operation takes approximately 40 minutes (around the same amount of time as a standard ACL operation using the hamstrings). All surgeries will be performed by Dr Kelly Macgroarty (FRACS orth) who is also the senior researcher.
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Intervention code [1]
312125
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Treatment: Surgery
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Knee injury and osteoarthritis outcome score (KOOS) (questionnaire)
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Assessment method [1]
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Timepoint [1]
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1 year
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Primary outcome [2]
307185
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American orthopaedic foot and ankle score (AOFAS) (questionnaire and clinical examination)
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Assessment method [2]
307185
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Timepoint [2]
307185
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1 year
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Secondary outcome [1]
350577
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Western Ontario and McMaster universities osteoarthritis index (WOMAC) (questionnaire)
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Assessment method [1]
350577
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Timepoint [1]
350577
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1 year
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Secondary outcome [2]
351045
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Lysholm score (questionnaire)
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Assessment method [2]
351045
0
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Timepoint [2]
351045
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1 year
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Secondary outcome [3]
351046
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Tegner activity rating scale (questionnaire)
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Assessment method [3]
351046
0
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Timepoint [3]
351046
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1 year
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Secondary outcome [4]
351047
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Range of movement (ROM) of knee measured with a goniometer
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Assessment method [4]
351047
0
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Timepoint [4]
351047
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6 months
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Secondary outcome [5]
351048
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Lachman grade (clinical examination)
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Assessment method [5]
351048
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Pivot shift grade (clinical examination)
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Assessment method [6]
351049
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Timepoint [6]
351049
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6 months
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Eligibility
Key inclusion criteria
Planned primary ACL reconstruction
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Minimum age
16
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Revision ACL reconstruction
Augmented ACL reconstruction
Multiligament reconstruction
Meniscal repair
Previous foot or ankle surgery
Chronic ankle instability
Under 16 years of age
Cannot read and understand english
Unable to give consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Outcome will be analysed in terms of clinical examination and patient related outcome for both the knee and the donor site (ankle). Quantitative data will be calculated.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/09/2018
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Actual
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Date of last participant enrolment
Anticipated
31/12/2018
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
11692
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St Andrew's War Memorial Hospital - Brisbane
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Recruitment postcode(s) [1]
23770
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4000 - Brisbane
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Funding & Sponsors
Funding source category [1]
300387
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Other Collaborative groups
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Name [1]
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Brisbane Knee and Shoulder Clinic
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Address [1]
300387
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St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
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Country [1]
300387
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Brisbane Knee and Shoulder Clinic
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Address
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
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Country
Australia
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Secondary sponsor category [1]
299841
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University
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Name [1]
299841
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Queensland University of Technology
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Address [1]
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Clinical Sciences Building, 5th Floor, The Prince Charles Hospital, Rode Road, Chermside QLD 4032
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Country [1]
299841
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301196
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Uniting care Health Human research ethics committee
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Ethics committee address [1]
301196
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UnitingCare Health Human Research Ethics Committee
The Wesley Hospital
PO Box 499
Auchenflower Qld 4066
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Ethics committee country [1]
301196
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Australia
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Date submitted for ethics approval [1]
301196
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04/05/2018
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Approval date [1]
301196
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13/07/2018
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Ethics approval number [1]
301196
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1809
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Summary
Brief summary
Several types of material are commonly used in anterior cruciate reconstruction (ACLR) with the majority of these coming from around the knee. Harvesting tendons may, however in itself cause pain and dysfunction. It is therefore desirable to identifly a harvesting method which does not lead to additional injury and possible dysfunction of the already injured knee while at the same time minimising such problems in other areas of the body.
In recent years a small number of studies have been published regarding the use of peroneus longus (a tendon on the outside of the leg) autograft (PLA). These studies suggests PLA is a safe graft choice for ligament reconstruction and causes minimal dysfunction at the harvest site (the ankle).
Our hypothesis is that PLA will perform as well as a hamstring tendon in ACLR while not causing pain and loss of strength in the knee nor significant dysfunction at the ankle .
The project may potentially lead to the identification of peroneus longus as a suitable graft choice for ACLR. After the pilot study is completed we plan to conduct a randomised trial of peroneus longus versus standard graft (hamstring) to identify whether peroneus longus is superior to standard technique. These studies may lead to an improvement in the standard of care for patients with ACL rupture.
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Trial website
N/A
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Trial related presentations / publications
None as yet
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Public notes
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Attachments [1]
3007
3007
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/AnzctrAttachments/375782-1809 Approval PLA study.pdf
(Ethics approval)
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Attachments [2]
3008
3008
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/AnzctrAttachments/375782-PLA clinical trial information sheet.docx
(Participant information/consent)
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Attachments [3]
3009
3009
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/AnzctrAttachments/375782-PLA ACLR Clinical Protocol.docx
(Protocol)
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Attachments [4]
3010
3010
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/AnzctrAttachments/375782-PLA study consent form.docx
(Participant information/consent)
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Contacts
Principal investigator
Name
86186
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Dr Kelly Macgroarty
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Address
86186
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Brisbane Knee and Shoulder Clinic
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
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Country
86186
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Australia
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Phone
86186
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+61 738321900
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Fax
86186
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Email
86186
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[email protected]
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Contact person for public queries
Name
86187
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Dr Jamie Brown
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Address
86187
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Brisbane Knee and Shoulder Clinic
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
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Country
86187
0
Australia
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Phone
86187
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1300 562 247
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Fax
86187
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Email
86187
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[email protected]
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Contact person for scientific queries
Name
86188
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Dr Jamie Brown
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Address
86188
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Brisbane Knee and Shoulder Clinic
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
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Country
86188
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Australia
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Phone
86188
0
1300 562 247
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Fax
86188
0
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Email
86188
0
[email protected]
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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.
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