Outcome of Two Different Suture Methods for Achilles Tendon Rupture

Study Overview
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Brief Summary
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The purpose of this study is to estimate the effective of two suture methods in the treatment of Achilles rupture.

Detailed Description
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Achilles tendon rupture is one of the most common tendon injuries in the adult population. The incidence of this injury is increasing as aging adults continue their participation in high-demand sports. Although the impact of an Achilles tendon rupture is substantial, often resulting in prolonged disability and rehabilitation. Studies have showed that the operation treatment of acute Achilles tendon ruptures had some advantages. But the rebuild of blood supply was not involved in previous studies. And the epitenon of tendon is the interior layer, closest to the endotenons which contains the vascular supply. Main difference of two suture methods were if the epitenon was repaired and sewed indirectly or unrepaired and sewed directly.

Official Title
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Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Procedure: sewed indirectly
* Procedure: sewed directly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men or women between 18 and 60 years of age. Closed rupture confirmed with ultrasound or magnetic resonance imaging (MRI). Operative within 14 days after injury. Willing and able to comply with and carry out the prescribed rehabilitation protocol. Providing informed consent. No other major trauma. Exclusion Criteria: Refuse to participate. Refuse to participate. Additional ipsilateral injury. Open injury. Patients not suitable for surgery (i.e., mellitus diabetes, immunocompromised states, obesity (BMI.30), peripheral vascular disease or local/systemic dermatologic disorders) or have other surgical contraindications. Fluoroquinolone-associated rupture (i.e., rupture within 2 weeks after taking this medication). Achilles avulsion from the calcaneus or with bone fracture. Neurological or vascular disease requiring medications recognized to impair tendon healing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indirectly<br>The epitenon was repaired and sewed indirectly. | Procedure: sewed indirectly<br>* The epitenon was repaired and sewed indirectly.<br>|
| Placebo Comparator: Directly<br>The epitenon was unrepaired and sewed directly. | Procedure: sewed directly<br>* The epitenon was unrepaired and sewed directly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood supply condition | Blood supply was estimated by ultrasonic contrast at six weeks after surgery. | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calf circumference | Calf circumference was measured at six weeks after surgery. | six weeks | 
| Complications | Infection and rerupture at six month after surgery. | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgery, suture method, blood supply