RecruitingACTRN12618000906257

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

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


Sponsor

Mark Porter

Enrollment

42 participants

Start Date

Jul 1, 2018

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Ankle sprains are the most common sports injury, and for about one in four people, the ankle never fully stabilises — leading to chronic instability that keeps giving way and causing pain. When physiotherapy hasn't fixed the problem, surgery is often recommended. The current gold standard operation is called the modified Brostrom-Gould (MBG) procedure, which tightens the stretched ligaments on the outside of the ankle. This trial is comparing the MBG procedure to an alternative approach that reinforces the ligament repair with a synthetic ligament called LARS (Ligament Augmentation and Reconstruction System). Some surgeons believe the synthetic augmentation might provide stronger, longer-lasting stability — particularly for athletes or people who don't qualify for the standard MBG procedure. You may be eligible if you are physically active (playing sport at least three times a week), are skeletally mature (growth plates closed), weigh under 90 kg, and have ongoing ankle instability despite physiotherapy. People with a history of previous ankle surgery, connective tissue disorders, or general ligament laxity are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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 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.


Locations(1)

ACT,NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12618000906257