Outcome After Surgical Reconstruction of the Achilles Tendon Insertion.

November 27, 2023 updated by: Krankenhaus Barmherzige Schwestern Linz

Functional Outcomes and Return to Sports After Surgical Treatment of Insertional Achilles Tendinopathy With Tendon Debridement and Anchor Refixation.

The purpose of this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The lifetime risk of Achilles tendon pain is approximately 6%, one-third of whom complain of pain at the bony attachment of the Achilles tendon to the calcaneus.

Primary treatment of these insertional tendinopathies is always nonsurgical with physical therapy, orthotics, shock wave therapy, or various forms of injections. If there is no response to therapy, surgery is warranted after three to six months. In this procedure, the tendon is detached from the bone, the damaged portions of the tendon are removed, bony prominences are rounded, and finally the tendon attachment is reconstructed and fixed with anchors. Various anchor systems are available for this purpose.

The double-row anchor system used by the investigators in recent years allows stable, knotless, two-dimensional refixation of the Achilles tendon to the calcaneus and thus permits rapid rehabilitation. Recent studies show good functional results 33 months after reconstruction of the Achilles tendon attachment with the "Speed Bridge" System. To the best of our knowledge, however, there are no studies to date on sports ability after this operation.

The investigators are therefore conducting a retrospective collection of clinical patient data combined with a planned (prospective) questionnaire survey of patients with insertional Achilles tendon tendinopathy who received surgical treatment with tendon refixation.

Study Type

Observational

Enrollment (Actual)

23

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

  • Austria
      • Linz, Austria, 4010
        • Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion between 01/2018 and 10/2021.

Description

Inclusion Criteria:

  • All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion due to an insertional tendinopathy of the Achilles tendon.

Exclusion Criteria:

  • Lack of informed consent
  • Revision surgery
  • Patients who had another operation on the same leg during the same procedure or 6 months later

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study Population
Patients who underwent surgical reconstruction of the Achilles tendon insertion using a knotless, double-row anchor system.
Procedure: Reconstruction of Achilles tendon insertion
knotless double-row anchor fixation of the achilles tendon insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to sports Rate
Time Frame: minimum 12 months from surgery to follow-up
in percentage compared to preoperatively
minimum 12 months from surgery to follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sport units per week, sport disciplines practiced
Time Frame: minimum 12 months from surgery to follow-up
in absolute numbers
minimum 12 months from surgery to follow-up
Length of sport units
Time Frame: minimum 12 months from surgery to follow-up
in minutes
minimum 12 months from surgery to follow-up
Range of motion after surgery
Time Frame: minimum 12 months from surgery to follow-up
in degrees
minimum 12 months from surgery to follow-up
Subjective change of instability after surgery
Time Frame: minimum 12 months from surgery to follow-up
Visual analog scale; 0-10; 0 means no instability, 10 means worst instability
minimum 12 months from surgery to follow-up
Change of pain after surgery
Time Frame: minimum 12 months from surgery to follow-up
Visual analog scale; 0-10; 0 means no pain, 10 means worst pain
minimum 12 months from surgery to follow-up
Satisfaction with result
Time Frame: minimum 12 months from surgery to follow-up
Visual analog scale; 0-10; 0 means not satisfied, 10 means maximum satisfaction
minimum 12 months from surgery to follow-up

Collaborators and Investigators

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

Sponsor

Krankenhaus Barmherzige Schwestern Linz

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)

September 13, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AST_2023

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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