Plantaris Release for Non-insertional Achilles Tendinopathy

NCT02775201 | Unknown

• 1 other identifier: 16/LO/0188
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy; Achilles Tendon

Keywords

plantaris; Tendinopathy; Achilles; Release

Outcome Measures

Primary Outcomes (2)

• VISA-A Questionnaire

  2 years

• Ultrasound Tissue Characterisation

  12 months

Study Arms (2)

Plantaris release under ultrasound guidance

ACTIVE COMPARATOR

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

Procedure: Plantaris excision surgically

Plantaris excision surgically

ACTIVE COMPARATOR

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

Procedure: Plantaris release under ultrasound guidance

Interventions

Plantaris release under ultrasound guidance PROCEDURE

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 surgically

Plantaris excision surgically PROCEDURE

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

Plantaris release under ultrasound guidance

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fortius Clinic: lead

Study Sites (1)

Fortius Clinic

London, W1H 6EQ, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 17604979 RESULT

• 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.

  PMID: 25394422 RESULT

• 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.

  PMID: 23131435 RESULT

• 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.

  PMID: 7892469 RESULT

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Central Study Contacts

Joanna M Stephen, PhD

CONTACT

020 3195 2442; jo.stephen@fortiusclinic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

GB (1)