- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04957069
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
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.
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