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TendinopathyNCT02775201

Plantaris Release for Non-insertional Achilles Tendinopathy

A study testing Plantaris release under ultrasound guidance and Plantaris excision surgically in people with Tendinopathy and Achilles Tendon, run by Fortius Clinic at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The plantaris tendon is recognised as an important factor in non-insertional Achilles tendinopathy (NIAT). A biomechanical study found the plantaris tendon is stiffer and stronger than the Achilles tendon (AT), thus reducing its capacity to elongate in response to loading. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Tendinopathy, Achilles Tendon
What is being tested?
Plantaris release under ultrasound guidance and Plantaris excision surgically
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited Kingdom
Study dates
May 2016to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A diagnosis of medially located NIAT confirmed by USS and MRI.
  • Participants having undergone at least one course of conservative intervention including physiotherapy which has been unsuccessful.

Who cannot join

  • 1. Any other co-existing lower limb injuries which would affect the outcome of patient reported outcome scores.

Trial locations and contacts

1 site in 1 country.

Joanna M Stephen, PhD contact

020 3195 2442

jo.stephen@fortiusclinic.com

United Kingdom1 site
  • Fortius Clinic

    London, W1H 6EQ

    Joanna M Stephen, PhD, 020 3195 2442, jo.stephen@fortiusclinic.com

    James DF Calder, MD, FRCS(Tr. & Orth.)

Other trials in United Kingdom

About this study

Official title: A Comparison of Intra-operative and Ultrasound Guided Plantaris Release for the Treatment of Non-insertional Achilles Tendinopathy

The plantaris tendon is recognised as an important factor in non-insertional Achilles tendinopathy (NIAT). A biomechanical study found the plantaris tendon is stiffer and stronger than the Achilles tendon (AT), thus reducing its capacity to elongate in response to loading. This is hypothesized to result in friction between the AT and plantaris in some NIAT patients. Current treatment is conservative management: physiotherapy and high volume injection of the paratenon. However 29% of patients fail to respond to conservative management and those with plantaris related symptoms require its surgical excision and stripping of the ventral aspect of the AT through a 3cm medial incision. This is performed in theatres under general anaesthetic with good or excellent results reported in 90% of cases.

Purely cutting the plantaris tendon using a minimally invasive endoscopic technique has also been successful. The plantaris tendon is easily visualized under ultrasound scan (USS) and tenotomy of tendons under USS guidance is performed elsewhere. Tenotomy of the plantaris tendon under USS guidance would necessitate a 5mm incision and may be performed under local anaesthetic as an out-patient. The current study thus plans a randomised clinical trial to compare outcomes (VISA-A scores and ultrasound tissue characterisation scans) from patients with NIAT undergoing plantaris release using an open surgical procedure with those undergoing a minimally invasive US guided procedure. The former is known to provide good clinical outcomes; however the latter could significantly reduce post-operative scarring, recovery times and costs. Findings will ensure ethical, quality and cost effective patient care.

Read the detailed description

Midportion Achilles tendinopathy has been found to have an incidence of 1.85 per 1000 in the general population and is reported to be a career-ending condition in up to 5% of professional athletes. The mainstay of treatment at present is typically prescription of eccentric strengthening exercises, activity modification and analgesia. If conservative intervention fails then surgery can be indicated, and a wide range of different procedures are described. Open Achilles surgery may be successful in 75-100% of patients but debridement with excision of areas of tendinosis weakens the tendon and can delay return to sport for up to 18 months.

There is currently a growing acceptance for the role of the plantaris tendon in the development of medial Achilles tendon (AT) pain and focal medial Achilles tendinopathy. The plantaris arises from the lateral aspect of the supracondylar line of the femur, passing from lateral to medial deep to medial gastrocnemius and superficial to soleus, inserting into the medial aspect of the calcaneus. However there is wide variation in the exact insertion of the plantaris tendon observed distally. A large study examining 750 limbs reported 4 types of distal insertion, a further study reported 3 different insertion sites, whilst a more recent study reported 9 variations. Consistently 10-20% of plantaris tendons are identified to have a direct structural attachment to the AT. This variety of insertion patterns may explain why some individuals are more prone to plantaris issues than others.

Friction of the plantaris tendon against the medial border of the Achilles tendon and subsequent pain and swelling is a significant problem in elite track and field athletes, with an annual injury incidence of 3.9-9.3% reported. Biomechanical studies have hypothesized that this is due to the plantaris tendon being stiffer and stronger than the Achilles tendon (AT), thus reducing its capacity to elongate in response to loading. This is thought to cause friction between the AT and plantaris contributing to peritendon inflammation, which can induce tendinopathy changes to the AT through either a neuro-inflammatory mediation or via a compressive mechanism.

Twenty nine percent of patients with NIAT fail to respond to conservative management and many have to give up sporting activities. Patients who continue to experience symptoms may be referred for a high volume injection of the paratenon under ultrasound scan (USS) guidance - this aims to strip the paratenon layer from the AT which often becomes adherent with fibrous bands. This also strips the neovascularization from the ventral surface of the AT - this abnormal tissue has nerve fibres within it and it is believed that this is a major pain generator in NIAT. However, it is recognised that a sub-group of patients with NIAT have isolated medially-located pain approximately 4-6cm from insertion into the os calcis. On USS and Magnetic Resonance Imaging (MRI) the plantaris tendon may be seen to attach to the medial aspect of the AT (either inserting into the side of the AT directly rather than the os calcis or becoming adherent with fibrous tissue to the AT medial border). This is at the level of the AT where it has undergone a 90 degree rotation and corresponds to the soleus part of the tendon. Since the plantaris tendon crosses 2 joints (originating above the knee and inserting into the os calcis) whereas the soleus only crosses one joint (the ankle) there may be a differential movement of the plantaris against the medial border of the AT creating a frictional syndrome with subsequent focal inflammation and then tendinosis of the AT.

The treatment for this "plantaris syndrome" if it fails to respond to conservative measures or USS guided injections is to remove the plantaris tendon and surgically strip the ventral aspect of the AT through a 3cm medial incision. This is performed in theatres under general anaesthetic with good or excellent results being reported in 90% and 94% of professional athletes returning to sport.3 However, there have been papers reporting on the successful treatment of patients purely cutting the plantaris tendon using a minimally invasive endoscopic technique.The plantaris tendon is easily visualized under USS and tenotomy of tendons under USS guidance is described elsewhere. Performing a tenotomy of the plantaris tendon under USS guidance would necessitate a 5mm incision and may be performed under local anaesthetic as an out-patient. Currently it is not known whether this is as good as the open surgical procedure performed in theatre and the investigators would propose a randomized study comparing the techniques.

The rationale for the current study therefore is to compare clinical outcomes and AT structural changes in patients with NIAT undergoing plantaris excision using an open surgical procedure to those undergoing a minimally invasive US guided procedure performed in an out-patient clinic. The former is known to provide good clinical outcomes however the latter could significantly reduce post-operative scarring, recovery times and surgical costs. Thus, if found to be comparable, treating these patients in the clinic with an ultrasound guided plantaris release would offer a desirable alternative to surgery and result in a change of current clinical interventions for this population.

Being tested
Plantaris release under ultrasound guidance, Plantaris excision surgically
Keywords
plantaris, Tendinopathy, Achilles, Release
Medical subject headings
Tendinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Plantaris release under ultrasound guidanceProcedure or surgery

    In patients diagnosed with Achilles tendinopathy the plantaris tendon will be released using a small incision at the medial ankle under ultrasound guidance by a consultant radiologist

  • Plantaris excision surgicallyProcedure or surgery

    In patients diagnosed with Achilles tendinopathy the plantaris tendon will be excised in theatre by a consultant orthopaedic surgeon

Study groups in NCT02775201
Study groupRoleWhat they receive
Plantaris release under ultrasound guidanceActive comparatorPatients diagnosed with non-insertional Achilles tendinopathy will have plantaris released under ultrasound guidance by a consultant radiologist
Receives: Procedure: Plantaris excision surgically
Plantaris excision surgicallyActive comparatorPatients diagnosed with non-insertional Achilles tendinopathy will have plantaris excised in surgery by a consultant orthopaedic surgeon
Receives: Procedure: Plantaris release under ultrasound guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VISA-A Questionnaire

    Measured: 2 years

  2. Ultrasound Tissue Characterisation

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionApr 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775201
Sponsor's protocol ID
16/LO/0188
Status last verified
May 2016
First submitted
13 May 2016
Last updated
1 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Andersson G, Danielson P, Alfredson H, Forsgren S. Nerve-related characteristics of ventral paratendinous tissue in chronic Achilles tendinosis. Knee Surg Sports Traumatol Arthrosc. 2007 Oct;15(10):1272-9. doi: 10.1007/s00167-007-0364-2. Epub 2007 Jun 29.

    PubMed 17604979
  • Calder JD, Freeman R, Pollock N. Plantaris excision in the treatment of non-insertional Achilles tendinopathy in elite athletes. Br J Sports Med. 2015 Dec;49(23):1532-4. doi: 10.1136/bjsports-2014-093827. Epub 2014 Nov 13.

    PubMed 25394422
  • Maffulli N, Spiezia F, Longo UG, Denaro V, Maffulli GD. High volume image guided injections for the management of chronic tendinopathy of the main body of the Achilles tendon. Phys Ther Sport. 2013 Aug;14(3):163-7. doi: 10.1016/j.ptsp.2012.07.002. Epub 2012 Nov 4.

    PubMed 23131435
  • Helms CA, Fritz RC, Garvin GJ. Plantaris muscle injury: evaluation with MR imaging. Radiology. 1995 Apr;195(1):201-3. doi: 10.1148/radiology.195.1.7892469.

    PubMed 7892469

Questions about this trial

What is this clinical trial studying?

A study testing Plantaris release under ultrasound guidance and Plantaris excision surgically in people with Tendinopathy and Achilles Tendon, run by Fortius Clinic at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Joanna M Stephen, PhD (020 3195 2442, jo.stephen@fortiusclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VISA-A Questionnaire (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775201, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.

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