- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04478383
Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.
Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new surgical technique and were followed for a mean time of 40 months. Clinical outcomes were measured using the visual analog scale (VAS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner score, and time taken to return to activities. Preoperative and postoperative MRI, the ability to perform heel rise, and complications were also evaluated.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Haidian District
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Beijing, Haidian District, China, 100191
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- clinical presentations and physical examination, routine ankle X ray and MRI
Exclusion Criteria:
- calcaneal tuberosity avulsion fractures
- Achilles tendon rerupture
- previous surgical procedure on the affected Achilles tendon
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of Victorian Institute of Sports Assessment-Achilles 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.
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from pre-surgery to two years after surgery
|
change of visual analog 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.
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from pre-surgery to two years after surgery
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change of American Orthopaedic Foot & Ankle Society 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.
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from pre-surgery to two years after surgery
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change of Tegner 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.
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from pre-surgery to two years after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2018008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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