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

NCT ID: NCT04465994

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-05
• Study Completion Date: 2020-05-05

Brief Summary

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.

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.

Conditions

Acute Rupture of Achilles Tendon (Disorder)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

primary repair

Patients with acute achilles tendon ruptures who received the treatment of primary repair.

No interventions assigned to this group

gastrocnemius turn-down flaps

Patients with acute achilles tendon ruptures who received the treatment of gastrocnemius turn-down flaps.

gastrocnemius turn-down flaps

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingfang Ao, MD

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

Peking Univerisity Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

M2019465

Identifier Type: -

Identifier Source: org_study_id