ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000906257

Ethics application status

Approved

Date submitted

19/05/2018

Date registered

30/05/2018

Date last updated

16/05/2019

Date data sharing statement initially provided

16/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Clinical trial comparing two surgical techniques used to treat instability of the ankle in those people who are normally involved in sports activities.

Scientific title

Lateral ligament augmentation versus modified Brostrom-Gould procedure for chronic lateral ankle instability: A randomised controlled trial.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Chronic lateral ankle instability

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The operation is performed with the patient under a general anaesthetic in an operating theatre. An examination under anaesthesia is performed and a diagnostic arthroscopy using two standard portals. The LARS procedure is performed using an anterolateral incision and approach to the ankle, similar to primary incision and approach to that used for the MBG procedure, with two additional 1cm incisions. The most distal incision is used to anchor the CFL limb of the LARS to the isometric insertion site on the calcaneum, and the proximal one is used to draw the LARS loop up the fibular tunnel and for individual tensioning of the ATFL and CFL. A 5mm tunnel is drilled in the fibula at the area where the ATFL and CFL attachments overlap, aiming proximally and posteriorly within the centre of the fibula, ensuring that the tunnel is at least 25mm long. A 4.5mm x 20mm blind ending tunnel is drilled at the distal insertion sites of the ATFL and CFL. A separate 1cm capsulotomy is performed at the insertion site of the ATFL so that the ATFL limb of the LARS will run in an extra-capsular location, while the CFL limb of the LARS will run from the distal insertion site deep to the peroneal tendons and capsule, again in an extracapsular location. Both limbs of the LARS are secured to their respective insertion sites using a 4.75 suture anchor (BioComposite SwiveLock, Arthrex Inc). Once the loop of the LARS is passed from distal to proximal along the fibular tunnel it can be retrieved via the most proximal incision the two limbs tensioned individually to create a stable ankle, and then secured using a third 4.75 mm SwiveLock. The excess loop is then excised flush with the posterior surface of the fibula. A simple repair of the LCL complex is then performed using absorbable suture (1-vicryl) with imbrication of the attenuated structure, before closing the wound in layers. The surgery take approximately 70 minutes to perform.
All patients are placed in a dorsal back slab until 7-10 days post-surgery. At this first post-operative review the wound is checked and the patients placed in a sub-talar stabilizing brace. The patient is allowed to weight bear as tolerable in the brace, and the rehabilitation program commenced under the supervision of the treating physiotherapist. The rehabilitation protocol aimed to return patients to full activity within 3-4 months of surgery.
The surgery is performed by the main author / researcher as described in the study protocol.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

The modified Brostrom-Gould procedure is currently the most commonly performed surgical procedure for this condition, and therefore was used as the comparator.
The procedure is performed in an operating theatre with the patient under a general anaesthetic. The initial examination under anaesthesia and ankle arthroscopy are performed as described above. A similar anterolateral incision and approach is made to the anterolateral capsule and ligaments
The ligaments are dissected out, divided, double breasted and reattached to bone using a double arm loaded Smith and Nephew Twin-Fix Ti titanium suture anchors with ultra-braid suture material . Three of these anchors are used and and both the ATFL and CFL are repaired in all cases. The surgery take approximately 70 minutes to perform.The post-operative protocol is similar to that for the LARS procedure described above.

Control group

Active

Outcomes

Primary outcome [1]

The Foot and Ankle Outcome score or FAOS is a patient-scored questionnaire validated for use following lateral ankle ligament injury. The patients scores their ankle in each of the following sub-scales "pain", "other symptoms", "activities of daily living", "sport and quality of life". The score for each sub-scale and the total score are calculated with 0 being the worst possible score and 100 the best possible score.

Timepoint [1]

Done prior to surgery, and then at 1 (primary endpoint), 2 and 5 years post surgery, and 5 year intervals thereafter for up to 20 years

Secondary outcome [1]

The occurrence of any complications is noted when the patient is assessed post-operatively by the surgeon. It is a separate outcome

Timepoint [1]

1,2, 5 & 10 years post surgery

Secondary outcome [2]

Tegner activity score - this a patient scored outcome which indicates the level of sports activity that they are are able to take part in, where 0 is the lowest possible score and 10 the highest. This is a validated questionnaire for use following knee or ankle injury.

Timepoint [2]

This is completed at the following time intervals - prior to surgery, and then 1,2, and 5 years post surgery and 5 yearly interval thereafter up to 20 years post surgery

Eligibility

Key inclusion criteria

Physically active (sport at least 3 times per week), skeletally mature, for for a general anaesthetic, body weight less than 90kg, remaining symptomatically unstable despite physiotherapy (that is having chronic lateral ankle instability)

Minimum age

12 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Complex ankle injuries, generalised ligamentous laxity, body weight > 90kg, previous ankle surgery, medical conditions contra-indicating general anesthetic, known connective tissue disease or rheumatologic conditions. Patients were excluded if they had relative contra-indications to the MBG procedure, otherwise the study may have been biased in favour of the LARS augmentation procedure.

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)

Because there were extra-incision associated with the LARS procedure (two small 1cm incisions, it was not possible to blind the patients from which procedure they had performed) and therefore allocation was not concealed.

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

Simple randomisation using the toss of a coin

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

A power analysis has been performed. Using a standard deviation of 5 units for the total FAOS, 19 patients were required in each group to achieve a power of 80%, with 95% significance. If 1 point is regarded as clinically important, in order to detect a significant difference between the mean Tegner activity scores in the two groups, 20 patients in each group would provide a power of 80% with 95% confidence.
The mean age of the patients in the two groups at baseline will be compared using analysis of variance (ANOVA) and the male:female ratio using chi-squared tests. Generalised linear models and multi-variate tests to will be used to compare the changes in the FAOS scores, both total scores and each sub-scale, seen within each group, at 1, 2, 5 and subsequent years following surgery, and the Tegner activity scores. T-tests and Mann-Whitney U test, will be used to compared the changes in FAOS scores during each time-interval following surgery. We set the significance level at P<0.05.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/07/2018

Actual

1/07/2018

Date of last participant enrolment

Anticipated

1/07/2025

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Mark Porter

Address [1]

Dr. Mark Porter
Suite 21 Calvary Clinic, Bruce,
ACT 2617

Country [1]

Australia

Primary sponsor type

Individual

Name

Mark Porter

Address

Mark Porter, COSM,
Suite 21 Calvary Clinic, Mary Potter Circuit,
BRUCE, ACT 2617

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

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, 9 Sydney Avenue, Barton, ACT, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/01/2018

Approval date [1]

18/01/2018

Ethics approval number [1]

Summary

Brief summary

Background: “Ankle sprain” is a common injury, and more than 20% of patients may develop chronic instability for which surgery is indicated. The modified Brostrom-Gould (MBG) procedure remains the gold standard, but there are a number of relative contra-indications to this procedure and the longer term outcomes following the MBG have been questioned. An alternative procedure is augmentation of a primary repair with a ligament augmentation reconstruction system (LARS).
What is known about the subject: Ankle sprains of the lateral ligaments are the commonest sport-related injury and approximately one quarter of patients have on-going symptoms of instability. The MBG procedure is the gold standard treatment but a significant number of patients have relative contraindications for this procedure, and there is a paucity of scientific evidence to support its popularity or long term efficacy. 
What this study may add to existing knowledge: A primary repair augmented with a synthetic ligament may result in a better patient-scored outcomes than the MBG and may not have the same relative contraindications. The use of this synthetic ligament to augment a primary repair may represent a safe and effective surgical alternative for management of ankle instability. However its efficacy need to be compared with that of the gold standard procedure, the modified Brostrom-Gould procedure (MBG). This ligament has been used for this indication before but there is no level evidence 1 or 2 to support its use. 
Study Design: Prospective Randomized Controlled Clinical Trial
Methods: Patients who satisfy the inclusion criteria will invited to take part in the study. Patients are randomly allocated to undergo the LARS procedure or MBG procedure. Both groups will follow a similar post-operative rehabilitation. Patients completed the Foot and Ankle Outcome Score (FAOS) before surgery, and then at 1, 2, 5 and subsequent years following surgery. Tegner activity scores are also recorded. The scores in the two groups will be compared using statistical analysis (P<0.05).

Trial website

n/a

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mark Porter

Address

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

Country

Australia

Phone

+61 (02) 6253 5404

Fax

mdporter@iinet.net.au

Contact person for public queries

Name

Mark Porter

Address

COSM, Suite 21 Calvary Clinic, Mary Potter Circuit, Bruce, ACT 2617

Country

Australia

Phone

+61 (02) 6253 5404

Fax

hello@cosm.net.au

Contact person for scientific queries

Name

Mark Porter

Address

COSM, Suite 21 Calvary Clinic, Mary Potter Circuite, Bruce ACT 2671

Country

Australia

Phone

+61 (02) 6253 5404

Fax

hello@cosm.net.au

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?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		American Journal of Sports Medicine, The American ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Ankle Lateral Ligament Augmentation Versus the Modified Brostrom-Gould Procedure: A 5-Year Randomized Controlled Trial.	2019	https://dx.doi.org/10.1177/0363546518820529

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically