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Plantaris Release for Non-insertional Achilles Tendinopathy

NCT02775201 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-06-01

No results posted yet for this study

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.

Conditions

  • Tendinopathy
  • Achilles Tendon

Interventions

PROCEDURE

Plantaris release under ultrasound guidance

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

PROCEDURE

Plantaris excision surgically

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

Sponsors & Collaborators

  • Fortius Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-04-30
Completion
2019-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02775201 on ClinicalTrials.gov