Comparison of Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture

Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture

This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, aiming to compare the mid-term curative effect of primary repair and gastrocnemius turn-down flaps and guide clinical decision.

Study Overview

• Status: Completed
• Conditions: Acute Rupture of Achilles Tendon (Disorder)
• Intervention / Treatment: Procedure: gastrocnemius turn-down flaps

Detailed Description

Objective: To explore the surgical methods and observe the med-term curative effect of primary repair and gastrocnemius turn-down flaps for acute Achilles tendon rupture, so as to guide clinical decision. Methods: This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, whose surgeries was completed by the sponsor with either primary repair or gastrocnemius turn-down flaps. The recovery and motor function of the patients were followed up by outpatient clinic and telephone at 3 months, 6 months, 12 months and 24 months after operation, respectively, so as to statistically analyze the med-term curative effects of two surgeries. Specific indicators include: Visual Analogue Scale, American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score, The Victorian Institute of Sport Assessment-Achilles, The Achilles tendon Total Rupture Score, the Tegner Activity Score, Biodex isokinetic dynamometer system, Postoperative rehabilitation index and complications.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking Univerisity Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 61 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This retrospective study includes 74 patients with acute Achilles tendon rupture from March 2012 to September 2018, including 68 male patients and 6 female patients. The average age is 36 years.

Description

Inclusion Criteria:

• history of Achilles tendon injury
• within two weeks of injury
• inability to single heel rise
• more than one year of follow-up
• age under 65

Exclusion Criteria:

• open Achilles tendon rupture
• Achilles tendon terminal disease
• rerupture of Achilles tendon
• history of local corticosteroid injection around the Achilles tendon
• accompanied by fracture, vascular or nerve damage
• not available for regular follow-up

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
primary repair; Patients with acute achilles tendon ruptures who received the treatment of primary repair.
gastrocnemius turn-down flaps; Patients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps.	Procedure: gastrocnemius turn-down flaps; We classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of Visual Analogue 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
change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot 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
change of The Victorian Institute of Sport Assessment-Achilles	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
change of The Achilles tendon Total Rupture 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
change of the Tegner Activity 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
Biodex	Biodex isokinetic dynamometer system	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	rerupture, infection, wound scar	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Yingfang Ao, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Primary repair; Achilles Tendon; Acute injury; gastrocnemius turn-down flaps
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: M2019465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No