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

Achilles Tendon Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03887585
• Other study ID #: Tendon
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2010
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2019
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: January 1, 2020
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Contracture
• Contracture

Intervention

Procedure:
• Achilles tendon lengthening
Achilles tendon lengthening by triple hemisection for Achilles tendon contracture

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before surgery and up to 8 years after surgery
Secondary	Equinus recurrence rate	The equinus recurrence rate of the patients after surgery is recorded. Lower value represents a better outcome.	Up to 8 years after surgery
Secondary	Infection rate	The infection rate of the patients after surgery is recorded. Lower value represents a better outcome.	Up to 8 years after surgery