Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)

March 8, 2021 updated by: Universitaire Ziekenhuizen KU Leuven
To evaluate the outcome of percutaneous paratenon release for chronic midportion Achilles tendinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since 2011 the percutaneous procedure took the place of the open release of the paratenon for the surgical treatment for chronic midportion Achilles tendinopathy in the investigators' center. In this study the investigators re-evaluate the patients undergoing percutaneous surgery since then in order to compare the outcome with the excellent results cited in literature. The patients will be contacted and asked to participate completing a VAS-score, a VISA-A score and agreeing with a clinical examination.

Approving by the Ethical Committee of UZLeuven is pending.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Pellenberg, Vlaams-Brabant, Belgium
        • University Hospitals of Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy

Description

Inclusion Criteria:

  • patients that underwent percutaneous paratenon release for chronic midportion Achilles tendinopathy

Exclusion Criteria:

  • insertional tendinopathy
  • open intervention
  • (partial) Achilles tendon rupture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
postoperative cases
patients that underwent percutaneous release of the paratenon for chronic midportion Achilles tendinopathy
Procedure: percutaneous paratenon release
percutaneous paratenon release for chronic midportion Achilles tendinopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISA-A-score
Time Frame: 3 months
specific questionnaire about (mal-)function of Achilles tendon
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36-score
Time Frame: 3 months
questionnaire about well-being
3 months
VAS-score
Time Frame: 3 months
questionnaire about pain
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Giovanni Matricali, MD, PhD, Foot and ankle surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S57392

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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