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Trial registered on ANZCTR


Registration number
ACTRN12620000819921
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
17/08/2020
Date last updated
17/08/2020
Date data sharing statement initially provided
17/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of knee position at the time of anatomic anterior cruciate ligament graft tensioning on post-operative knee extension and anterior tibial translation
Scientific title
The effect of knee position at the time of anatomic anterior cruciate ligament graft tensioning on post-operative knee extension and anterior tibial translation
Secondary ID [1] 299124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament tear 314188 0
Anterior cruciate ligament reconstruction 314189 0
Condition category
Condition code
Surgery 312547 312547 0 0
Surgical techniques
Musculoskeletal 316223 316223 0 0
Other muscular and skeletal disorders
Injuries and Accidents 316224 316224 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two orthopaedic surgeons with over 20 years of clinical experience will carry out anterior cruciate ligament (ACL) reconstructions on patients with deficient ACLs. This will occur in the surgical theatre of a private hospital. The patients were to have this surgery regardless of participation in the study. During the ACL reconstruction, a hamstring graft will be tensioned first in flexion and then in extension. Using computer navigation, baseline measurement of anisometricity, extension range and tibial rotation will be recorded. The graft will be tensioned and provisionally fixed with the knee flexed beyond is anisometric point and the extension range will be recorded. Following this first set of measures, the graft will be fixed in full extension and range as well as tibial rotation will be recorded. The difference in range of motion between tensioning in flexion versus tensioning in full extension will be compared. This will be compared with the range of motion and laxity of the non-operative knee. The rest of the surgery will then follow as per the standard ACL reconstruction technique by this surgeon. There will be no changes to post-operative care or rehabilitation. Data collected on day of surgery will be used for the analysis to test hypothesis. The additional measures adds 10 minutes to the standard procedure.
Intervention code [1] 315399 0
Treatment: Surgery
Comparator / control treatment
. The range of motion in the operative leg will be compared with that of the non-operative leg.
Control group
Active

Outcomes
Primary outcome [1] 321196 0
Quantify the loss of extension associated with tensioning the ACL graft with the knee in full extension versus in flexion. Preoperative extension and flexion of operative and non-operative knee will be assessed under anaesthesia using a digital inclinometer. Using computer navigation intraoperatively, the knee extension range and tibiofemoral rotation in full extension will be measured. Post operative assessments will be repeated using the same assessment method as performed preoperatively.
Timepoint [1] 321196 0
Day 0 (Day of surgery)
Secondary outcome [1] 374293 0
To quantify the anterior laxity of the knee after ACL reconstruction and assess whether the native knee laxity has been restored (by comparing with the non-operative knee). Preoperative anterior tibial translation (of both knees) will be performed using a Rolimeter). Post operative assessments will be repeated using the same assessment method as performed preoperatively.
Timepoint [1] 374293 0
Day 0 (Day of Surgery)
Secondary outcome [2] 374294 0
To quantify the rotational constraint of the knee after ACL reconstruction and assess whether the native rotational constraint has been restored (by comparing with the non-operative knee). On the operative limb, graded pivot shift test will be performed preoperative and immediately post-operative.
Timepoint [2] 374294 0
Day 0 (Day of Surgery)

Eligibility
Key inclusion criteria
Patients scheduled to undergo Anterior Cruciate Ligament Reconstructions under the care of the investigating surgeons
Patients with an isolated ACL injury
Male and female
Age 16 - 90
Able to provide informed consent
Patients with BMI < 40
Minimum age
16 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with ligament injuries other than ACL injury (determined from magnetic resonance imaging and clinical review)
Patients with previous knee surgery in operative knee
Patients with BMI > 40
Patients who are pregnant or planning to become pregnant during the course of the study
Patients unable to provide informed 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
Other
Other design features
Patients will all undergo surgery as per surgeons standard surgical technique for ACL reconstruction. There is no allocation to one specific technique, every patient will under go the same Intraoperative assessment methods.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation assuming Type I error (alpha) to 5% (p = 0.05) and Type II error (beta) to 0.2 (power equal to 80%) to calculate the desired sample size. The initial data to be used for this study is all from the Day of Surgery, therefore no loss to follow up has been calculated.
All data will be analysed using PRISM Version 7.
Statistical comparisons will be performed using the ANOVA tests with Bonferroni corrections for multiple comparisons. Statistical significance will be set at P<0.05. The relationship between rotation before and after graft tensioning will be measured with the paired t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
31/08/2018
Date of last data collection
Anticipated
Actual
28/02/2019
Sample size
Target
22
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14654 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 27680 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 303665 0
Charities/Societies/Foundations
Name [1] 303665 0
Orthopaedic Research Institute of Queensland
Country [1] 303665 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orthopaedic Research Institute of Queensland
Address
7 Turner St, Pimlico
QLD 4812, Australia.
Country
Australia
Secondary sponsor category [1] 303773 0
None
Name [1] 303773 0
Address [1] 303773 0
Country [1] 303773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304186 0
Mater Health Servcies North Queensland Human Research Ethics Committee
Ethics committee address [1] 304186 0
Ethics committee country [1] 304186 0
Australia
Date submitted for ethics approval [1] 304186 0
01/08/2014
Approval date [1] 304186 0
12/08/2014
Ethics approval number [1] 304186 0
MHS20140812-02

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96078 0
Dr Peter McEwen
Address 96078 0
Suite 3
Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country 96078 0
Australia
Phone 96078 0
+61 7 4779 4788
Fax 96078 0
+61 7 4728 6988
Email 96078 0
peter@kneesurgeon.com.au
Contact person for public queries
Name 96079 0
Andrea Grant
Address 96079 0
The Orthopaedic Research Institute of Queensland
Mater Hospital
Fulham Rd, Pimlico
QLD 4812, Australia.
Country 96079 0
Australia
Phone 96079 0
+61 7 4755 0564
Fax 96079 0
Email 96079 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 96080 0
Peter McEwen
Address 96080 0
Suite 3
Level 2 Mater Medical Centre
21-37 Fulham Road
Pimlico QLD 4812
Country 96080 0
Australia
Phone 96080 0
+61 7 4779 4788
Fax 96080 0
+61 7 4728 6988
Email 96080 0
peter@kneesurgeon.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patients did not consent to the sharing of their personal/private information at the time that they completed their consent for being part of the study.


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.