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A trial to compare two different surgical techniques used to prevent the unstable knee cap from further episodes of dislocation in patients at significant risk or recurrence.

Medial patello-femoral ligament reconstruction using hamstring autograft versus use of the ligament augmentation reconstruction system (LARS): a prospective randomised controlled trial comparing clinical outcomes, and recurrence rates, in physically active patients.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000778189
Acronym
n/a
Enrollment
86
Registered
2019-05-27
Start date
2019-07-01
Completion date
2020-12-31
Last updated
2023-01-16

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

Conditions

None listed

Brief summary

Instability of the knee cap is a common problem and has a high recurrence rate, even with appropriate physiotherapy. When it has recurred, surgery becomes the necessary treatment. The surgical technique most commonly used involves the use of one of the patient's hamstrings to make a new ligament, the medial patello-femoral ligament. This technique uses one of the patient's own hamstrings and there is increased pain and an increased risk of complications associated with taking the hamstring graft. An artificial ligament, referred to as the ligament augmentation reconstruction system (LARS), is an alternative ligament that has been used for this operation, instead of the hamstring graft. This has the potential benefit of less pain, and a lower risk of complications. However there is no research to compare the outcomes of the two techniques used to reconstruct the ligament. The goal of the study was to compare the patient outcomes in patients undergoing the operation with the use of a hamstring graft versus the use of the LARS graft. Patients who are appropriate candidates and who agree to take part in the study, are randomly allocated to group 1 who have a hamstring graft, or group 2 who have a LARS ligament. Both groups will follow the same rehabilitation protocol to be supervised by a physiotherapist. Patients are allowed to weight bear as tolerable with a brace on, and the range of motion permitted in the brace is gradually increased over a period of 8 weeks. After this the patient can wean from the use of the brace. Patients can expect to make a complete recovery within 4 months of the surgery. The outcomes of interest are a questionnaire referred to as the Kajula score and Tegner activity score. These are completed before surgery and again at 1, 2, and 5 years post surgery. The results will be compared using statistical analysis.

Interventions

All patients will be undergoing a surgical reconstruction of the medial patellofemoral ligament, performed by an orthopaedic surgeon. The operation takes 60-90 minutes to perform. The first part of the operation is an arthroscopy and then the reconstruction is performed if appropriate. Patients are randomised using a computer program, at this stage. Arm 1 of the study, will undergo a reconstruction of the medial patellofemoral ligament using one of their own hamstrings. Arm 2 will have a similar

All patients will be undergoing a surgical reconstruction of the medial patellofemoral ligament, performed by an orthopaedic surgeon. The operation takes 60-90 minutes to perform. The first part of the operation is an arthroscopy and then the reconstruction is performed if appropriate. Patients are randomised using a computer program, at this stage. Arm 1 of the study, will undergo a reconstruction of the medial patellofemoral ligament using one of their own hamstrings. Arm 2 will have a similar procedure performed, except a ligament made of polyethylene terephthalate is used instead of the autograft. The two procedures differ only in the nature of the graft use. The operation is performed with the patient under a general anaesthetic. All patient have a standard arthroscopy performed, via two portals in the knee (one anteromedial and one anterolateral). A complete arthroscopic assessment of the knee is performed and any cartilage lesions noted and / or treated. Following this a small incision is made along the medial border of the patella and a second on over the medial epicondyle (ME) of the distal femur. The graft (LARS or hamstring) is attached to the medial border of the patella using 2 x bioabsorable suture anchors and then passed along the course of the native MPFL, immediately superficial and apposed to it, to its attachment at the medial epicondyle, where it is attached to the ME using a third anchor. The anchors used are bioabsorbable. For patients in Arm 1, the hamstring graft is harvested via a small incision placed over the attachment of the gracilis tendon to the proximal medial tibial, and a tendon harvested used to separated the tendon from its muscle, resulting in a tendon graft approximately 20cm long and 3mm in diameter. For patients in Arm 2, the artificial ligament is used instead of the hamstring graft. The results of the randomisation and the operation performed by the operation performed, are recorded and any discrepancy will be noted during the follow-up. All patients are placed in a range of motion brace for 2 months post surgery, in which they are allowed to bear full weight. They both follow the same physiotherapy-supervised rehabilitation program which commences around 2 weeks post surgery. The latter requires 1 x 1 hour physiotherapy weekly for a total of 8 weeks. These are 1 on 1 physiotherapy sessions. The physiotherapist instructs the patient in quadriceps recruitment and control exercise, as well as co-contractions in the range 0-45dg for 3 weeks, and then 0-90dg for the following 3 weeks. They come out of the brace at 2 months post surgery, and progress their strength and balance. Running in straight lines is possible around 3 months post surgery and return to full sport can vary from 4-6 months post surgery.

Sponsors

Mark D Porter
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

History of patellar dislocation with examination findings consistent with this diagnosis (positive patellar apprehension test, MRI findings consistent with this diagnosis - bone bruising pattern and MPFL disruption or attenuation) Physically active - involved in physical activity at least 3 times per week Skeletally mature - closed epiphyses about the knee on imaging (MRI, CT, or x-rays) No previous surgery on the knee Failed 6 weeks course of physiotherapy Intact collateral and cruciate ligaments No meniscal injury

Exclusion criteria

Rheumatological or connective tissue disease Generalized ligamentous laxity Unfit for a general anesthetic Previous knee surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026