Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture

March 21, 2019 updated by: Xiaojun Duan, Southwest Hospital, China
This study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aims to provide a new therapeutic theory which bases on the percutaneous sliding technique with three hemi-cuts in the tendon. In this study, Achilles tendon parenchymal at distal level is hemisected through the most distal incision, Achilles tendon parenchymal at proximal level is hemisected through the middle incision, then Achilles tendon lengthening is accomplished by the sliding tendon under forceful dorsiflexion. It can better achieve soft tissue balance and reduce the recurrence of Achilles tendon contracture when Achilles tendon strength in plantarflexion is weakened. Thus in this study, the partial aponeurosis of gastrocnemius is cut off at most proximal incision in order to weaken Achilles tendon strength in plantarflexion.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • China
      • Chongqing, China
        • Southwest Hospital

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

1 year to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than three years old;
  • Severe Achilles tendon contracture and equinus;
  • The time after Achilles tendon contracture more than 6 months ;
  • Initial Achilles tendon lengthening.

Exclusion Criteria:

  • Patients younger than 3 years;
  • The course of Achilles tendon contracture is within 6 months;
  • Patients who have suffered from the Achilles tendon lengthening;
  • Obvious contracture of other soft tissues occurs in combination, such as compartment syndrome or extensive scar tissues in calf;
  • Osteotomy or tendon transposition is needed.
  • Ankle joint is damaged obviously, such as Charcot's joint or Hemophilic arthritis;
  • Skin soft-tissue infection in the lower limb.
  • Initial Achilles tendon lengthening.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Achilles tendon lengthening
Surgery of percutaneous Achilles tendon lengthening by triple hemisection
Procedure: Achilles tendon lengthening
Achilles tendon lengthening by triple hemisection for Achilles tendon contracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores
Time Frame: Before surgery and up to 8 years after surgery
The AOFAS scores of the patients before and after surgery are recorded. The scale ranges from 0-100 points, and increases of the value represent a better outcome.
Before surgery and up to 8 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equinus recurrence rate
Time Frame: Up to 8 years after surgery
The equinus recurrence rate of the patients after surgery is recorded. Lower value represents a better outcome.
Up to 8 years after surgery
Infection rate
Time Frame: Up to 8 years after surgery
The infection rate of the patients after surgery is recorded. Lower value represents a better outcome.
Up to 8 years after surgery

Collaborators and Investigators

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

Sponsor

Southwest Hospital, China

Investigators

  • Principal Investigator: Xiaojun Duan, MD, Southwest Hospital, China

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)

January 1, 2010

Primary Completion (Actual)

September 30, 2018

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tendon

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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