Comparison of Surgical Outcomes Between Avulsion Fracture of the AT and Conventional ATR--a Retrospective Study

July 4, 2021 updated by: Peking University Third Hospital

Comparison of Surgical Outcomes Between Avulsion Fracture of the Achilles Tendon and Conventional Achilles Tendon Rupture--a Retrospective Study

To compare the surgical outcomes between avulsion fracture of the Achilles tendon and conventional Achilles tendon rupture, collected and analysed information of patients preoperatively and postoperatively.

Study Overview

Detailed Description

Include 30 patients with avulsion fracture of the Achilles tendon and 30 patients with Achilles tendon rupture underwent surgical treatment in our institute. Collect and evaluate MRI, VAS, AOFAS, and FFI score preoperatively and postoperatively. Finally explore the surgical outcomes between avulsion fracture of the AT and conventional ATR.

Study Type

Observational

Enrollment (Actual)

60

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

From 2013 to 2017, patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture that underwent surgical treatment in our institute.

Description

Inclusion Criteria:

  • patients with avulsion fracture of the Achilles tendon or Achilles tendon rupture

Exclusion Criteria:

  • neuromuscular related diseases
  • other injuries of ankle joint

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Avulsion fracture
avulsion fracture of the Achilles tendon
double row fixation with 3-4 wire anchors
Rupture
Achilles tendon rupture
end-to-end repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOCART
Time Frame: one year after sugery
MOCART is a scoring system to evaluate the repair effect of cartilage injury.The minimum and maximum values of MOCART are 100 and 0, respectively. And higher scores mean a better outcome.
one year after sugery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: pre-surgery, one year after sugery
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.
pre-surgery, one year after sugery
AOFAS
Time Frame: pre-surgery, one year after sugery
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.
pre-surgery, one year after sugery
FFI
Time Frame: pre-surgery, one year after sugery
A Foot Function Index (FFI) was developed to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The FFI was examined for test-retest reliability, internal consistency, and construct and criterion validity. Each scale is from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) .
pre-surgery, one year after sugery

Collaborators and Investigators

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

Investigators

  • Study Chair: Qinwei Guo, 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)

January 1, 2013

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 12, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • M2018040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Achilles Tendon Rupture

Clinical Trials on fixation

Subscribe