Trial Review

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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
Scientific title
Patient outcome following peroneus longus autograft anterior cruciate ligament reconstruction in patients with anterior cruciate ligament rupture
Secondary ID [1] 295795 0
Nil known
Universal Trial Number (UTN)
U1111-1218-9213
Trial acronym
PLA ACL reconstruction
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament rupture 309228 0
Condition category
Condition code
Surgery 308101 308101 0 0
Surgical techniques
Musculoskeletal 308213 308213 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312125 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307079 0
Knee injury and osteoarthritis outcome score (KOOS) (questionnaire)
Timepoint [1] 307079 0
1 year
Primary outcome [2] 307185 0
American orthopaedic foot and ankle score (AOFAS) (questionnaire and clinical examination)
Timepoint [2] 307185 0
1 year
Secondary outcome [1] 350577 0
Western Ontario and McMaster universities osteoarthritis index (WOMAC) (questionnaire)
Timepoint [1] 350577 0
1 year
Secondary outcome [2] 351045 0
Lysholm score (questionnaire)
Timepoint [2] 351045 0
1 year
Secondary outcome [3] 351046 0
Tegner activity rating scale (questionnaire)
Timepoint [3] 351046 0
1 year
Secondary outcome [4] 351047 0
Range of movement (ROM) of knee measured with a goniometer
Timepoint [4] 351047 0
6 months
Secondary outcome [5] 351048 0
Lachman grade (clinical examination)
Timepoint [5] 351048 0
6 months
Secondary outcome [6] 351049 0
Pivot shift grade (clinical examination)
Timepoint [6] 351049 0
6 months

Eligibility
Key inclusion criteria
Planned primary ACL reconstruction
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11692 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 23770 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 300387 0
Other Collaborative groups
Name [1] 300387 0
Brisbane Knee and Shoulder Clinic
Country [1] 300387 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brisbane Knee and Shoulder Clinic
Address
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
Country
Australia
Secondary sponsor category [1] 299841 0
University
Name [1] 299841 0
Queensland University of Technology
Address [1] 299841 0
Clinical Sciences Building, 5th Floor, The Prince Charles Hospital, Rode Road, Chermside QLD 4032
Country [1] 299841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301196 0
Uniting care Health Human research ethics committee
Ethics committee address [1] 301196 0
UnitingCare Health Human Research Ethics Committee
The Wesley Hospital
PO Box 499
Auchenflower Qld 4066
Ethics committee country [1] 301196 0
Australia
Date submitted for ethics approval [1] 301196 0
04/05/2018
Approval date [1] 301196 0
13/07/2018
Ethics approval number [1] 301196 0
1809

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.
Trial website
N/A
Trial related presentations / publications
None as yet
Public notes
Attachments [1] 3007 3007 0 0
/AnzctrAttachments/375782-1809 Approval PLA study.pdf (Ethics approval)
Attachments [2] 3008 3008 0 0
/AnzctrAttachments/375782-PLA clinical trial information sheet.docx (Participant information/consent)
Attachments [3] 3009 3009 0 0
/AnzctrAttachments/375782-PLA ACLR Clinical Protocol.docx (Protocol)
Attachments [4] 3010 3010 0 0
/AnzctrAttachments/375782-PLA study consent form.docx (Participant information/consent)

Contacts
Principal investigator
Name 86186 0
Dr Kelly Macgroarty
Address 86186 0
Brisbane Knee and Shoulder Clinic
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
Country 86186 0
Australia
Phone 86186 0
+61 738321900
Fax 86186 0
Email 86186 0
[email protected]
Contact person for public queries
Name 86187 0
Jamie Brown
Address 86187 0
Brisbane Knee and Shoulder Clinic
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
Country 86187 0
Australia
Phone 86187 0
1300 562 247
Fax 86187 0
Email 86187 0
[email protected]
Contact person for scientific queries
Name 86188 0
Jamie Brown
Address 86188 0
Brisbane Knee and Shoulder Clinic
St Andrew’s Specialist Suites
St Andrew’s War Memorial Hospital
457 Wickham Terrace Brisbane Qld 4000
Country 86188 0
Australia
Phone 86188 0
1300 562 247
Fax 86188 0
Email 86188 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.