Clinical trial NCT04465994: Comparison of Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture
Official title: Comparison of Mid-term Curative Effect After Primary Repair Versus Gastrocnemius Turn-down Flaps of Acute Achilles Tendon Rupture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Rupture of Achilles Tendon (Disorder)
Keywords: Achilles Tendon
Acute injury
Primary repair
gastrocnemius turn-down flaps
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 74
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: change of Visual Analogue Scale
timeFrame: from pre-surgery to two years after surgery
measure: change of American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
timeFrame: from pre-surgery to two years after surgery
measure: change of The Victorian Institute of Sport Assessment-Achilles
timeFrame: from pre-surgery to two years after surgery
measure: change of The Achilles tendon Total Rupture Score
timeFrame: from pre-surgery to two years after surgery
measure: change of the Tegner Activity Score
timeFrame: from pre-surgery to two years after surgery
measure: Biodex
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: complications
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univerisity Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yingfang Ao, MD
role: STUDY_CHAIR
References: