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A prospective randomized controlled trial investigating peroneus longus versus hamstring tendon autograft in anterior cruciate ligament reconstruction

A prospective randomized controlled trial investigating the recovery of strength and function following peroneus longus tendon autograft versus hamstring tendon autograft in anterior cruciate ligament reconstruction

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001055493
Enrollment
76
Registered
2025-09-24
Start date
2025-11-03
Completion date
2027-12-03
Last updated
2025-09-29

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

Conditions

None listed

Brief summary

This is a prospective randomized controlled trial (RCT) comparing patient outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two autograft constructs: 1) a hamstring tendon (HT) autograft, or 2) a peroneus longus tendon (PLT) autograft. Patient outcomes will be collected and compared between the two surgical autograft cohorts over a 24 month post-operative period. This will include limb symmetry index of peak isokinetic knee flexor strength at 12 months (primary outcome variable), a range of patient reported outcome measures (PROMs), objective measures including anterior knee laxity, knee range of motion (ROM), quadriceps and hamstring strength, ankle eversion and plantarflexion strength, and functional performance tests including single limb hop and vertical/horizontal jump capacity. Donor site morbidity will also be assessed using specific questionnaires and patient-reported measures. It is hypothesised that patients undergoing ACL reconstruction via PLT autograft, will have earlier recovery of knee flexion strength and lower donor site morbidity compared with patients receiving a HT autograft.

Interventions

This is a prospective, single-blinded randomized controlled trial (RCT) comparing outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two autograft constructs: 1) a hamstring tendon (HT) autograft, or 2) a peroneus longus tendon (PLT) autograft. The intervention (the surgical procedure with one of the two graft types) will be administered by the treating orthopaedic surgeon. While both constructs are used in clinical practice, for the purpose of trial r

This is a prospective, single-blinded randomized controlled trial (RCT) comparing outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two autograft constructs: 1) a hamstring tendon (HT) autograft, or 2) a peroneus longus tendon (PLT) autograft. The intervention (the surgical procedure with one of the two graft types) will be administered by the treating orthopaedic surgeon. While both constructs are used in clinical practice, for the purpose of trial registration the ‘intervention’ is the PLT autograft surgical construct. The surgical time for both techniques is approximately 45 minutes. This may be extended by 15–20 minutes if concomitant meniscal repair is performed. The appropriate intervention will be ensured in all patients via internal monitoring by the research team, liaising with a specific member of the nursing team independent of the study but present at all surgeries. Adherence to the intervention (or surgery type) is monitored through surgical operation records, which document graft type, concomitant procedures, and intraoperative details. Following surgery, postoperative rehabilitation will follow standard clinical practice under the direction of the patient’s own physiotherapist or exercise physiologist. This will typically involve therapist visits 1–2 times per week as required over the initial 12 weeks, followed by periodic supervised therapy from 3–12 months post-surgery. Initially, all patients without meniscal repair will be permitted to weight bear as tolerated using crutches. Where meniscal pathology requires repair, restrictions on weight bearing or loaded range of motion will follow the meniscal protocol until full weight bearing is allowed. Briefly, and standardized across all patients, early rehabilitation will focus on reducing pain and swelling, restoring knee range of motion, and regaining quadriceps control. From 2–3 weeks, outpatient rehabilitation will include progressive exercises dictated by individual conditioning and progression. From 6 weeks, emphasis will shift to single-leg strengthening. From 3 months, a criterion-based return to jogging, hopping, and jumping will be initiated, progressing to higher-level sport-specific activities as tolerated.

Sponsors

Perth Orthopaedic and Sports Medicine Research Institute
Lead SponsorCharities/Societies/Foundations

Study design

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

Eligibility

Sex/Gender
All
Age
16 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

• The individual is 16 years of age or above at the time of surgery. • The individual clinically qualifies for ACLR surgery based on clinical examination and MRI. • The ACLR surgery is combined with meniscal surgery (meniscectomy or meniscal repair) which is addressed concomitantly with the ACLR. • The individual has sustained the ACL tear within the last 12 months.

Exclusion criteria

• The individual is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board. • The individual is classified as morbidly obese (>40.0 body mass index). • The individual is skeletally immature. • The ACLR is combined with another ligament reconstruction or repair in the knee (multi- ligament knee procedure). • Revision procedures. • The individual has undergone ACLR previously on the contralateral limb. • The ACLR is combined with complex meniscal or chondral pathology that significantly alters the surgical pathway and standard rehabilitation program.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026