Comparison of Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture

July 9, 2020 updated by: Peking University Third Hospital

Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture

This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: To explore the surgical methods and observe the med-term curative effect of primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to guide clinical decision. Methods: This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and motor function of the patients were followed up by outpatient clinic and telephone at 3 months, 6 months, 12 months and 24 months after operation, respectively, so as to statistically analyze the med-term curative effects of two surgeries. Specific indicators include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative rehabilitation index and complications.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

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
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking Univerisity Third 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 61 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, including 68 male patients and 6 female patients. The average age is 36 years.

Description

Inclusion Criteria:

  • history of Achilles tendon injury
  • within two weeks of injury
  • inability to single heel rise
  • more than one year of follow-up
  • age under 65

Exclusion Criteria:

  • open Achilles tendon rupture
  • Achilles tendon terminal disease
  • rerupture of Achilles tendon
  • history of local corticosteroid injection around the Achilles tendon
  • accompanied by fracture, vascular or nerve damage
  • not available for regular follow-up

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
primary repair
Patients with acute achilles tendon ruptures who received the treatment of primary repair.
gastrocnemius turn-down flaps
Patients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps.
Procedure: gastrocnemius turn-down flaps
We classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of Visual Analogue Scale
Time Frame: from pre-surgery to two years after surgery
The Visual Analogue Scale (VAS) is designed to present to the respondent a rating scale with minimum constraints. Respondents mark the location on the 10-centimeter line corresponding to the amount of pain they experienced. This gives them the greatest freedom to choose their pain's exact intensity. It also gives the maximum opportunity for each respondent to express a personal response style. The minimum and maximum values of VAS are 10 and 0, respectively. And higher scores mean a worse outcome.
from pre-surgery to two years after surgery
change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time Frame: from pre-surgery to two years after surgery
The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score combines subjective scores of pain and function provided by the patient with objective scores based on the surgeon's physical examination of the patient (to assess sagittal motion, hindfoot motion, ankle-hindfoot stability and alignment of the ankle-hindfoot). The scale includes nine items that can be divided into three subscales (pain, function and alignment). The minimum and maximum values of AOFAS are 100 and 0, respectively. And higher scores mean a better outcome.
from pre-surgery to two years after surgery
change of The Victorian Institute of Sport Assessment-Achilles
Time Frame: from pre-surgery to two years after surgery
The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
from pre-surgery to two years after surgery
change of The Achilles tendon Total Rupture Score
Time Frame: from pre-surgery to two years after surgery
The VISA-A questionnaire displayed construct validity when used in two populations of patients with Achilles tendinopathy and control subjects. The questionnaire avoids the redundant components of non-specific scoring systems such as that developed for hind foot problems by the American Orthopaedic Society, and those devised for Achilles tendon rupture. Results range from 0 to 100, where 100 represents the perfect score.
from pre-surgery to two years after surgery
change of the Tegner Activity Score
Time Frame: from pre-surgery to two years after surgery
The Tegner activity scale was first described in 1985 and initially designed for physician administration after ACL and meniscal injuries. To date, the Tegner activity score has been a frequently used patient-administered activity rating system for patients with various knee disorders. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
from pre-surgery to two years after surgery
Biodex
Time Frame: through study completion, an average of 2 years
Biodex isokinetic dynamometer system
through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
complications
Time Frame: through study completion, an average of 2 years
rerupture, infection, wound scar
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yingfang Ao, MD, Peking University Third Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2019465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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