Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique

Sponsor
Peking University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04478383
Collaborator
(none)
11
1
9
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: a new transosseous suture technique

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 Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
May 1, 2018

Outcome Measures

Primary Outcome Measures

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

  2. change of visual analog scale [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.

  3. change of American Orthopaedic Foot & Ankle Society score [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.

  4. change of Tegner score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Haidian District China 100191

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04478383
Other Study ID Numbers:
  • M2018008
First Posted:
Jul 20, 2020
Last Update Posted:
Jul 20, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2020