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Plantaris Release for Non-insertional Achilles Tendinopathy

Primary Purpose

Tendinopathy, Achilles Tendon

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Plantaris release under ultrasound guidance
Plantaris excision surgically
Sponsored by
Fortius Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring plantaris, Tendinopathy, Achilles, Release

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Fortius Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Plantaris release under ultrasound guidance

Plantaris excision surgically

Arm Description

Patients diagnosed with non-insertional Achilles tendinopathy will have plantaris released under ultrasound guidance by a consultant radiologist

Patients diagnosed with non-insertional Achilles tendinopathy will have plantaris excised in surgery by a consultant orthopaedic surgeon

Outcomes

Primary Outcome Measures

VISA-A Questionnaire
Ultrasound Tissue Characterisation

Secondary Outcome Measures

Full Information

First Posted
May 13, 2016
Last Updated
May 31, 2016
Sponsor
Fortius Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02775201
Brief Title
Plantaris Release for Non-insertional Achilles Tendinopathy
Official Title
A Comparison of Intra-operative and Ultrasound Guided Plantaris Release for the Treatment of Non-insertional Achilles Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fortius Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Achilles Tendon
Keywords
plantaris, Tendinopathy, Achilles, Release

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plantaris release under ultrasound guidance
Arm Type
Active Comparator
Arm Description
Patients diagnosed with non-insertional Achilles tendinopathy will have plantaris released under ultrasound guidance by a consultant radiologist
Arm Title
Plantaris excision surgically
Arm Type
Active Comparator
Arm Description
Patients diagnosed with non-insertional Achilles tendinopathy will have plantaris excised in surgery by a consultant orthopaedic surgeon
Intervention Type
Procedure
Intervention Name(s)
Plantaris release under ultrasound guidance
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Plantaris excision surgically
Intervention Description
In patients diagnosed with Achilles tendinopathy the plantaris tendon will be excised in theatre by a consultant orthopaedic surgeon
Primary Outcome Measure Information:
Title
VISA-A Questionnaire
Time Frame
2 years
Title
Ultrasound Tissue Characterisation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1. Any other co-existing lower limb injuries which would affect the outcome of patient reported outcome scores.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna M Stephen, PhD
Phone
020 3195 2442
Email
jo.stephen@fortiusclinic.com
Facility Information:
Facility Name
Fortius Clinic
City
London
ZIP/Postal Code
W1H 6EQ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanna M Stephen, PhD
Phone
020 3195 2442
Email
jo.stephen@fortiusclinic.com
First Name & Middle Initial & Last Name & Degree
James DF Calder, MD, FRCS(Tr. & Orth.)

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17604979
Citation
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.
Results Reference
result
PubMed Identifier
25394422
Citation
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.
Results Reference
result
PubMed Identifier
23131435
Citation
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.
Results Reference
result
PubMed Identifier
7892469
Citation
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.
Results Reference
result

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Plantaris Release for Non-insertional Achilles Tendinopathy

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