RecruitingPhase 1ACTRN12606000389505

An evaluation of knee stability and functions following ACL reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).

An evaluation of knee stability and functions following Anterior Cruciate Ligament (ACL) reconstruction (semitendinosus/gracillis grafts) comparing manually versus mechanically tensioned grafts (using a tensioning device).


Sponsor

Queensland Health

Enrollment

50 participants

Start Date

Jul 14, 2006

Study Type

Interventional

Conditions

Summary

We hypothesise that participants receiving a mechanically tensioned ACL graft have superior knee stability and hence function.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a special device to apply a set tension to the new ligament during ACL (anterior cruciate ligament) reconstruction surgery leads to better knee stability and function compared to the surgeon doing it by hand. The ACL is the ligament inside your knee that stops it from buckling. When it tears — often from sport or a fall — surgery is needed to replace it with a tendon graft. Getting the right tension on the graft is important for a stable and well-functioning knee. This study compares the two tensioning methods to see which gives better results. You may be eligible if: - You are an adult between 18 and 40 years old - You have a confirmed torn ACL and are having primary (first-time) ACL reconstruction surgery - You are otherwise healthy and able to complete the required rehabilitation program - You can understand and follow instructions - You are willing to give written informed consent You may NOT be eligible if: - You have a serious medical condition (such as cancer or severe lung disease) that would prevent rehabilitation - You are unable to walk on two legs (with or without a walking aid) - You cannot put full weight on your leg after the operation - You have had previous major knee surgery on the same knee - You are not suitable for a hamstring tendon graft - You have also injured your knee cartilage, other ligaments, or other parts of the leg Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Two tensioning methods for ACL reconstruction will be used: 1.Manual Tensioning (control group-semitendinosus/gracillis grafts) 2.Tensioning with a Graft Tensioner (intervention group-a tensioning dev

Two tensioning methods for ACL reconstruction will be used: 1.Manual Tensioning (control group-semitendinosus/gracillis grafts) 2.Tensioning with a Graft Tensioner (intervention group-a tensioning device). Both groups will follow the same postoperative protocols. Estimated time for procedure 70 mins Surgical protocol Tensioning Device Intervention Group: The graft is fixed to the tensioning device via suture tying The grafts are tensioned to 60 N for Semitendinosis and 40 Nfor gracillis The knee is cycled 15 times through full range of motion The tension is checked and adjusted so that 50 N remain on the semitendinosis graft and 30 N on the gracillis graft The tibial screw is then fixed in situ with the tension maintained The femoral fixation will be standardised Post Operative Management Both groups will be reconstructed using the semitendinosus/gracilis graft. The same postoperative protocols will be adhered to which involves an accelerated rehabilitation approach. The aim of this protocol is normal gait no aids by 2 weeks, normal range of movement, and minimal swelling within 6 weeks, and the aim of returning to sport in 6-9 months. Patients will be assessed preoperatively, and at 2 weeks, 3, 6 and 12 months post operatively using the measures outlined above.


Locations(1)

Australia

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ACTRN12606000389505