The Tape Locking Screw Technique: A new Anterior Cruciate Ligament (ACL) reconstruction technique

The Tape Locking Screw Technique: A new ACL reconstruction technique and the Impact of the tape locking screw technique on postoperative mobility

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000100392

Enrollment

100

Registered

2017-01-18

Start date

2017-03-01

Completion date

2018-03-30

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

Eligible participants include those with an ACL Injury recorded within 5 months requiring surgery that also have a normal opposite knee

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

Outcome results