Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000100392p
Ethics application status
Not yet submitted
Date submitted
20/12/2016
Date registered
18/01/2017
Date last updated
18/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Tape Locking Screw Technique: A new Anterior Cruciate Ligament (ACL) reconstruction technique
Scientific title
The Tape Locking Screw Technique: A new ACL reconstruction technique and the Impact of the tape locking screw technique on postoperative mobility
Secondary ID [1] 290790 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament injury 301436 0
Condition category
Condition code
Surgery 301155 301155 0 0
Surgical techniques
Musculoskeletal 301156 301156 0 0
Other muscular and skeletal disorders
Injuries and Accidents 301315 301315 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of two surgical techniques to repair anterior cruciate ligament injury. The tape locking system which is the device was developed in 2003 by FH Orthopaedics. It is a single tendon harvest prepared into a short four to five strand closed loop, with a diameter of 8 to 10mm and a 500N pre-load. The tunnels are shorter that the conventional methods of ACL repair and are created in a retrograde manner. The TLS system is to be compared against conventional ACL reconstruction technique which is a double (semitendinosus/ gracillus) tendon harvest. The TLS procedure may take between one to two hours. Both techniques will be performed by a consultant orthopaedic surgeon. Participants will be allocated into one of two groups depending upon ther preferred treatment of the consultant. 50 participants will be randomised to one orthopaedic surgeons who will perform the TLS surgical technique for ACL reconstruction and 50 participants will be randomised orthopaedic surgeons who perform the conventional ACL reconstruction technique.
Intervention code [1] 296705 0
Treatment: Surgery
Comparator / control treatment
The conventional ACL reconstruction technique used in the control group is a double (semitendinosus/ gracillus) tendon harvest.The surgeon drills small holes into the upper and lower leg bones where these bones come close together at the knee joint. The holes form tunnels through which the graft is anchored.
Control group
Active

Outcomes
Primary outcome [1] 300566 0
Pain which will, be assessed using the visual analogue scale to rate pain
Timepoint [1] 300566 0
12 months post procedure
Secondary outcome [1] 330325 0
Strength to be assessed at harvest site , contralateral limb (flexion strength at varying angles. Flexion strength will also be assessed by internal rotations and 1 leg hop test.:
Timepoint [1] 330325 0
12 months post procedure
Secondary outcome [2] 330792 0
Laxity to be assessed via anterior draw
Timepoint [2] 330792 0
12 months
Secondary outcome [3] 330793 0
Overall knee movement to be assessed via IKDC score, Tegner Lysholm score, and Cincinattl score
Timepoint [3] 330793 0
12 months

Eligibility
Key inclusion criteria
Eligible participants include those with an ACL Injury recorded within 5 months requiring surgery that also have a normal opposite knee
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Previous knee surgery (excluding diagnostic arthroscopy/ meniscus surgery)
*Associated ligament injury
*Grade 3-4 chondral damage
*Abnormal radiographs
*Unable to attend OPD clinic appointments at the PAH

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
30/03/2018
Actual
Date of last data collection
Anticipated
30/03/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7169 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 14929 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 295215 0
Hospital
Name [1] 295215 0
Princess Alexandra Hospital
Country [1] 295215 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road
Woolloongabba 4102
Queensland
Country
Australia
Secondary sponsor category [1] 294043 0
None
Name [1] 294043 0
Address [1] 294043 0
Country [1] 294043 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296561 0
Metro South HREC
Ethics committee address [1] 296561 0
199 Ipswich Road
Woolloongabba 4102
Queensland
Ethics committee country [1] 296561 0
Australia
Date submitted for ethics approval [1] 296561 0
19/01/2017
Approval date [1] 296561 0
Ethics approval number [1] 296561 0

Summary
Brief summary
A comparison of the Tape Locking Screw (TLS) in Anterior Cruciate Ligament (ACL) reconstruction technique and conventional Anterior Cruciate Ligament reconstruction surgical technique.

Hypothesis:
The TLS ACL reconstruction technique has superior post-operative outcomes compared to conventional ACL reconstruction techniques.
a) The single (semitendinosus) tendon harvest has less functional detriment compared with the double (semitendinosus/ gracillus) tendon harvest
b) Retrograde tunnelling has superior post-operative outcomes compared to traditional anterograde tunnelling
c) TLS fixation with 500N of pre-loading has better functional outcomes compared to a non-tensioned hamstring tendon graft
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71294 0
Dr Cameron Cooke
Address 71294 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba 4102
Queensland
Country 71294 0
Australia
Phone 71294 0
+61 7 3176 6640
Fax 71294 0
+61 7 3176 5156
Email 71294 0
[email protected]
Contact person for public queries
Name 71295 0
Mrs Genni Lynch
Address 71295 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba 4102
Queensland
Country 71295 0
Australia
Phone 71295 0
+61 7 31766640
Fax 71295 0
+61 7 31765156
Email 71295 0
[email protected]
Contact person for scientific queries
Name 71296 0
Mr Genni Lynch
Address 71296 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba 4102
Queensland
Country 71296 0
Australia
Phone 71296 0
+61 7 31766640
Fax 71296 0
+61 7 31765156
Email 71296 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.