RecruitingACTRN12616000708459

Clinical Outcome of Anterior Cruciate Ligament Plus Lateral Extra-articular Tenodesis Compared to Isolated Anterior Cruciate Ligament Reconstruction: A Feasibility Study

Clinical Outcome of Anterior Cruciate Ligament Plus Lateral Extra-articular Stabilisation Compared to Isolated Anterior Cruciate Ligament Reconstruction in 18 to 40 year old patients to compare the return to function and re-rupture rates between the two treatment modalities


Sponsor

Toby Leys

Enrollment

40 participants

Start Date

Mar 7, 2017

Study Type

Interventional

Conditions

Summary

The anterior cruciate ligament (ACL) is an important stabilizing ligament of the knee. It is also the most common knee ligament injury requiring surgery, with an annual incidence of approximately 1 in 3500 in the general population. Numerous technological advances have been made in recent times in the surgical techniques for ACL reconstruction but, in spite of this, the failure rate remains approximately 7-15% and many people do not return to full function in their knee after ACL reconstruction. The anterolateral ligament (ALL), a structure located in the anterolateral part of the knee, has recently been identified as an important contributor to rotational stability of the knee in addition to the ACL. Loss of ALL integrity may be responsible for some cases of failure post-operatively. Although intra-articular ACL reconstruction remains the current gold standard for operative management, it does not address the extra-articular ALL deficiency and therefore does not restore normal knee kinematics. The aim of this study is to compare the return to function and re-rupture rates following combined ACL reconstruction with lateral extra-articular tenodesis versus an isolated intra-articular ACL reconstruction. Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively during which the physiotherapist will make an assessment using a variety of objective knee scoring systems and a patient satisfaction survey. Any post-operative complications will also be recorded. Comparison will then be made to determine which technique has better functional outcome and lower re-rupture rate.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is comparing two different surgical techniques for repairing a torn anterior cruciate ligament (ACL) — the important stabilising ligament in the knee. One technique adds an extra procedure called a lateral extra-articular tenodesis (LET), which also repairs a related structure on the outside of the knee. The other technique is the standard ACL reconstruction only. The study aims to find out whether the combined approach leads to better knee function and fewer re-tears. You may be eligible if: - You are between 18 and 40 years old - You have a confirmed ACL tear on MRI - You have significant knee instability (Grade 2 or 3 on the pivot shift test) - You are medically fit to undergo general or regional anaesthesia You may NOT be eligible if: - You have injuries to other knee ligaments that also require surgery - You do not speak English - You live interstate or overseas - You are unable to give your own consent Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibi

Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. The duration of each procedure is approximately 45-60 minutes and will be performed by the consultant orthopaedic surgeon and his team. Post-operatively, participants will undertake a standard rehabilitation protocol for ACL reconstruction. Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively. Participants will no longer receive the yearly questionnaire, as stated previously.


Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12616000708459


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