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

Primary Purpose

Achilles Tendon Contracture

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Achilles tendon lengthening
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Contracture

Eligibility Criteria

3 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Achilles tendon lengthening

Arm Description

Surgery of percutaneous Achilles tendon lengthening by triple hemisection

Outcomes

Primary Outcome Measures

Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores
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

Equinus recurrence rate
The equinus recurrence rate of the patients after surgery is recorded. Lower value represents a better outcome.
Infection rate
The infection rate of the patients after surgery is recorded. Lower value represents a better outcome.

Full Information

First Posted
March 20, 2019
Last Updated
March 21, 2019
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03887585
Brief Title
Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
Official Title
Modified Percutaneous Achilles Tendon Lengthening by Triple Hemisection for Achilles Tendon Contracture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2010 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Contracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Achilles tendon lengthening
Arm Type
Experimental
Arm Description
Surgery of percutaneous Achilles tendon lengthening by triple hemisection
Intervention Type
Procedure
Intervention Name(s)
Achilles tendon lengthening
Intervention Description
Achilles tendon lengthening by triple hemisection for Achilles tendon contracture
Primary Outcome Measure Information:
Title
Changes in the American Orthopaedic Foot & Ankle Society (AOFAS) scores
Description
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.
Time Frame
Before surgery and up to 8 years after surgery
Secondary Outcome Measure Information:
Title
Equinus recurrence rate
Description
The equinus recurrence rate of the patients after surgery is recorded. Lower value represents a better outcome.
Time Frame
Up to 8 years after surgery
Title
Infection rate
Description
The infection rate of the patients after surgery is recorded. Lower value represents a better outcome.
Time Frame
Up to 8 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Duan, MD
Organizational Affiliation
Southwest Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
Country
China

12. IPD Sharing Statement

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

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