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CompletedNCT04478383Updated Jul 20, 2020

Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique

An observational study in Achilles Tendon Rupture and Fracture, Avulsion, sponsored by Peking University Third Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2020-07-20.

Sponsored by Peking University Third Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
11
Sex
All
01

Study summary

This retrospective study identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.

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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.

02

Conditions studied

  • Achilles Tendon Rupture
  • Fracture, Avulsion

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Keywords

  • Sleeve Avulsion
  • Achilles Tendinopathy
  • Suture, transosseous
  • Achilles Tendon
03

In context

Fractures, Avulsion

16 studies on the registry are indexed under Fractures, Avulsion; 4 are open to participants now.

Browse Fractures, Avulsion studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

One patient was lost to follow-up because she could not be contacted, having moved out of the country. The remaining 11 patients (10 men and one woman, average age: 46 years) were reviewed with an average follow-up time of 40 months (30-57 months).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • clinical presentations and physical examination, routine ankle X ray and MRI

Exclusion criteria

Exclusion Criteria:

  • calcaneal tuberosity avulsion fractures
  • Achilles tendon rerupture
  • previous surgical procedure on the affected Achilles tendon
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
11 participants (actual)
Patient registry
No

Interventions

  • Procedurea new transosseous suture technique

    a new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion.

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What researchers measure

Primary outcomes

  1. change of Victorian Institute of Sports Assessment-Achilles score

    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.

    Time frame: from pre-surgery to two years after surgery

  2. change of visual analog scale

    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.

    Time frame: from pre-surgery to two years after surgery

  3. change of American Orthopaedic Foot & Ankle Society score

    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.

    Time frame: from pre-surgery to two years after surgery

  4. change of Tegner score

    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.

    Time frame: from pre-surgery to two years after surgery

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Study locations

1 site
  • Peking University Third Hospital
    Beijing, Haidian District 100191, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04478383
Responsible party
Sponsor
First posted
Jul 20, 2020
Start date
Aug 1, 2017
Primary completion
Feb 1, 2018
Completion
May 1, 2018
Last update
Jul 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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