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Single versus double hamstring tendon graft in anterior cruciate ligament (ACL) reconstruction in the paediatric patient

Single versus double hamstring tendon graft in anterior cruciate ligament (ACL) reconstruction in the paediatric patient: a single blind randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001170910
Enrollment
100
Registered
2020-11-09
Start date
2021-09-14
Completion date
2025-04-23
Last updated
2026-09-07

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

Conditions

None listed

Brief summary

The diagnosis of anterior cruciate ligament (ACL) injury and reconstruction (ACLR) in skeletally immature patients is climbing at a rate significantly higher than adults. The increased incidence has been attributed to several factors including rise in competitive sport participation, decreased incidental activity, increased clinical awareness of a potential for ACL tear in this population, more comprehensive diagnosis and evaluation with Magnetic Resonance Imaging (MRI) and a shift in clinical practice to provide early intervention. The weight of available evidence now supports reconstruction over conservative management with minimal complications. Nonetheless, evidence regarding the ideal surgical technique for the skeletally immature patient is still lacking. Two commonly implemented surgical methods are reconstruction using single or double hamstring tendon autograft. The primary aim of this single blind randomized controlled trial is to determine whether a single or double hamstring tendon graft ACLR leads to superior clinical outcomes post-surgery in paediatric patients with ACL injury.

Interventions

Procedure name: Single hamstring tendon ACL reconstruction Approximate procedure duration: 1.5 hours Two senior surgeons will perform all surgeries at the Queensland Children’s Hospital. Both have been allowed a surgical learning curve of 20 cases (minimum) before the start of the trial. Smith&Nephew (S&N) UltraButton + round ExtendoButton will be used. Tendon harvest and graft preparation: The semitendinosus hamstring tendon be harvested for the single graft technique. A tendon stripper will b

Procedure name: Single hamstring tendon ACL reconstruction Approximate procedure duration: 1.5 hours Two senior surgeons will perform all surgeries at the Queensland Children’s Hospital. Both have been allowed a surgical learning curve of 20 cases (minimum) before the start of the trial. Smith&Nephew (S&N) UltraButton + round ExtendoButton will be used. Tendon harvest and graft preparation: The semitendinosus hamstring tendon be harvested for the single graft technique. A tendon stripper will be used to release the tendons from their proximal attachment via a standard push technique to a length of approximately 22cm. Graft preparation for the single hamstring technique will involve tripling the single semitendinosus tendon over two S&N UltraButton loops (with a round ExtendoButton being attached to the tibial UltraButton). The ends of the tendon complex are sutured via a whip-stitch technique using a #1 Ethibond suture on a J-needle. The prepared tendon complex will be set aside and soaked in a Vancomycin laden Raytec sponge. Once prepared, the graft is measured for both length (to ensure that the graft will adequately span the knee joint and sufficiently pass through both tunnels) and diameter (to determine the required femoral and tibial tunnel diameters for reaming). Knee arthroscopy and tunnel drilling: These are comparable between interventions and therefore will not be elaborated here. Graft passing and fixation: The nylon suture is pulled through the tibial tunnel so that the loop end is exiting out of the tibial tunnel. The graft is orientated and the Ethibond sutures are placed through the nylon loop. The Ethibond sutures are passed through the tibial and femoral tunnels and out of the skin of the anterolateral thigh. The arthroscope is placed into the knee joint and the Ultrabutton loop and graft are pulled into the femoral tunnel under vision to the line drawn on the graft from previous measurements. The Ultrabutton is toggled and flipped on the femoral side. The graft is held taught and the Femoral Ultraloop is reduced pulling the graft into the femoral tunnel to its desired length (~20mm). The knee is then brought out to 30-40 degrees flexion, and the tibial Ultraloop is reduced to pull the graft into the tibial tunnel. Final tensioning of the graft is done with knee extended to 0 degrees flexion the ExtendoButton is secured down to the tibia. Post-operative care and rehabilitation: These are comparable between interventions and therefore will not be elaborated here. Protocol adherence: A data monitoring committee will convene every 6 months to monitor post randomisation protocol adherence, patient safety and treatment efficacy during the surgical stage of the trial.

Sponsors

Queensland Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

All consecutive patients between the age of 8 and 18 who present to the orthopaedic outpatient’s clinic at the Queensland Children’s Hospital with an isolated ACL +/- meniscal injury

Exclusion criteria

Potential participants will be excluded if they have (1) concomitant posterior cruciate ligament injury, (2) collateral ligament instabilities of grade I or greater (2 to 5 mm), (3) bilateral ACL injury, (4) combined knee surgery with high tibial osteotomy or medial patellofemoral ligament, (5) evidence of early knee osteoarthritis on MRI, (6) previous knee surgery on the affected side, (7) chronic musculoskeletal conditions, (8) BMI > 35 and/or (9) booked for additional lateral tenodesis.

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 19, 2026