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Trial registered on ANZCTR

Registration number

ACTRN12619000778189

Ethics application status

Approved

Date submitted

11/05/2019

Date registered

27/05/2019

Date last updated

11/01/2023

Date data sharing statement initially provided

27/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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.

Scientific title

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.

Secondary ID [1]

nil

Universal Trial Number (UTN)

n/a

Trial acronym

n/a

Linked study record

n/a

Health condition

Health condition(s) or problem(s) studied:

Patellar instability

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Arm 1 is the control group. These patients undergoing the MPFL reconstruction using the hamstring graft to perform the operation as described above.

Control group

Active

Outcomes

Primary outcome [1]

Kujala scores (a validated patient-scored outcome for patellar instability)

Timepoint [1]

Baseline (prior to surgery, and the 1, 2 and five years post surgery. The primary end point will be 2 years post surgery

Secondary outcome [1]

Tegner activity scores, a validated patient-scored outcome for patellar instability

Timepoint [1]

1,2 and 5 years post surgery

Secondary outcome [2]

Recurrent patellar instability/ surgery.. All further episodes of instability will be noted during the follow-up period and / or further surgery required.
Patients will be reviewed at these time points and the results are recorded in the surgeons computerised notes. There is only one surgeon involved in the study and all details are recorded in the surgeon's database.

Timepoint [2]

1,2 and 5 years post surgery

Eligibility

Key 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

Minimum age

12 Years

Maximum age

50 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelop

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computer generated sequence

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive analysis of the patient population means and ranges will be performed for continuous variables. Discrete variables will be reported as percentages and frequencies. Generalised linear models will be use to evaluate patient reported outcomes. 2 sided hypothesis testing will be used, and statistical significance will be set at P<0.05. A post-hoc power analysis will be performed and the patients will be recruited until the power of the study is 80%

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2019

Actual

1/07/2019

Date of last participant enrolment

Anticipated

1/07/2021

Actual

31/12/2020

Date of last data collection

Anticipated

Actual

31/12/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Recruitment hospital [1]

Calvary Private Hospital ACT - Bruce

Recruitment postcode(s) [1]

2600 - Canberra

Recruitment postcode(s) [2]

2617 - Bruce

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

N/a

Country [1]

Primary sponsor type

Individual

Name

Mark D Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, Bruce, ACT 2617, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Barton Private Hospital Medical Advisory and Ethics Committee

Ethics committee address [1]

Barton Private Hospital 
3 Sydney Avenue
Barton, ACT 2600

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/04/2019

Approval date [1]

01/05/2019

Ethics approval number [1]

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mark Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61 02 62535404

Fax

+61262016802

[email protected]

Contact person for public queries

Name

Mark Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61 02 62535404

Fax

+61262016802

[email protected]

Contact person for scientific queries

Name

Mark Porter

Address

Canberra Orthopaedics and Sports Medicine, Suite 21 Calvary Clinic, Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61 02 62535404

Fax

+61262016802

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18007	Ethical approval			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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