Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique

Achilles Tendon Rupture Clinical Trial

Official title:

Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04478383
• Other study ID #: M2018008
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Fracture, Avulsion
• Rupture

Intervention

Procedure:
• a 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Haidian District

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from pre-surgery to two years after surgery
Primary	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.	from pre-surgery to two years after surgery
Primary	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.	from pre-surgery to two years after surgery
Primary	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.	from pre-surgery to two years after surgery