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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887585
Recruitment Status : Unknown
Verified March 2019 by Xiaojun Duan, Southwest Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaojun Duan, Southwest Hospital, China

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Achilles Tendon Contracture Procedure: Achilles tendon lengthening Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : September 30, 2018
Estimated Study Completion Date : January 1, 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887585


Locations
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China
Southwest Hospital
Chongqing, China
Sponsors and Collaborators
Southwest Hospital, China
Investigators
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Principal Investigator: Xiaojun Duan, MD Southwest Hospital, China
More Information
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Responsible Party: Xiaojun Duan, vice dean, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03887585    
Other Study ID Numbers: Tendon
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases