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Quadriceps versus Hamstrings Tendon Graft for Medial Patellofemoral Ligament (MPFL) Reconstruction in Paediatric Patients

Effect of Quadriceps versus Hamstrings Tendon Graft for Medial Patellofemoral Ligament (MPFL) Reconstruction on Knee Pain, Symptoms and Stability in Paediatric Patients: A Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000545369
Enrollment
50
Registered
2026-04-30
Start date
2026-06-01
Completion date
2028-06-01
Last updated
2026-05-04

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 study is a prospective randomised controlled trial (RCT) investigating post-operative clinical outcomes in paediatric patients undergoing medial patellofemoral ligament (MPFL) reconstruction for recurrent patellofemoral instability using either a quadriceps tendon (QT) graft or a hamstring tendon (HT) graft. Outcomes will be collected from baseline (pre-operative) through to 24 months post-operatively and will include patient-reported outcomes, objective functional measures (clinical examination, strength and performance testing) and radiological measures.

Interventions

This is a prospective randomized controlled trial (RCT) comparing outcomes in paediatric patients undergoing medial patellofemoral ligament (MPFL) reconstruction with one of two graft constructs: 1) a graft constructed by the patient's own harvested hamstring tendon (HT), or 2) a graft constructed by the patient's own harvested quadriceps tendon (QT). The HT graft is harvested from the hamstring tendons at the back of the thigh and above the knee, while the QT graft is harvested from the quadri

This is a prospective randomized controlled trial (RCT) comparing outcomes in paediatric patients undergoing medial patellofemoral ligament (MPFL) reconstruction with one of two graft constructs: 1) a graft constructed by the patient's own harvested hamstring tendon (HT), or 2) a graft constructed by the patient's own harvested quadriceps tendon (QT). The HT graft is harvested from the hamstring tendons at the back of the thigh and above the knee, while the QT graft is harvested from the quadriceps tendon at the front of the thigh and above the knee. Each graft is harvested at the beginning of the surgical procedure, and then subsequently used to reconstruct the new MPFL. The intervention (the surgical procedure with one of the two graft types) will be administered by the treating orthopaedic surgeon. While both constructs are generally used interchangeably, for the purpose of trial registration the 'intervention' is the QT graft. The surgical time for both techniques remains the same, and takes approximately 45 minutes in length. This 45-minute period includes both the graft harvest and the reconstructive procedure (i.e. the entire surgical procedure). The appropriate intervention will be ensured in all patients via internal monitoring by the research team, liaising with a specific member of the research team that is independent to the research study team and on-site for all surgeries). Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual therapist. This rehabilitation program will generally require therapist visits every 1-2 weeks as required over the initial 12 weeks (as is the case through standard clinical practice), followed by periodic supervised therapy from 3-9 months post-surgery. Briefly and, standardized across all patients, early in-patient exercises will focus on regaining knee range of motion (ROM), patella mobility and pain/swelling reduction. From 2-3 weeks post-surgery, out-patient rehabilitation (including the exact exercises, together with recommended sets, repetitions and loads) will be dictated by individual patient physical conditioning and progression. An initial focus on exercises to restore movement and bilateral functional weight bearing strength will be prescribed. From 6-weeks post-surgery, a focus on single leg strength capacity will be undertaken, with a criterion-based return to jogging, as well as jumping and hopping exercises from 3 months post-surgery.

Sponsors

Perth Children's Hospital
Lead SponsorHospital

Study design

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

Eligibility

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

Inclusion criteria

· The individual is aged 8 to 18 years with patellofemoral instability. · The individual clinically qualifies for MPFL reconstruction (with or without concomitant tibial tubercle transfer) based on clinical examination and radiological imaging. · The individual has a history of recurrent patella instability episodes (dislocations or subluxations). · The individual is undergoing unilateral MPFL reconstruction surgery. · Individuals who have had contralateral MPFL reconstruction may be included if they meet all other inclusion and exclusion criteria. · Individuals who have had previous guided growth surgery may be included if they meet all other inclusion and exclusion criteria; this will be recorded in baseline demographics.

Exclusion criteria

· The individual (and parent/guardian where applicable) is unable or unwilling to provide written informed consent/assent as approved by the HREC. · The individual (and parent/guardian) is unable or unwilling to complete the required pre-operative and post-operative follow up assessments (including imaging where applicable). · Morbid obesity (at or beyond a boday mass index of 40). · Significant comorbidities (e.g., Trisomy 21) that are likely to materially alter the post-operative recovery protocol or functional outcome assessment. · Formal diagnosis of a connective tissue disorder (e.g., Ehlers-Danlos or Marfan’s syndrome). · Clinically significant genu valgum deformity (intermalleolar distance at or beyond 10cm) at time of surgery (note: patients with previous guided growth surgery that has successfully corrected alignment may be eligible). · Revision MPFL reconstruction or prior patellofemoral stabilisation surgery on the proposed surgical side.

Outcome results

None listed

Source: ANZCTR · Data processed: May 7, 2026