Outcome of Two Different Suture Methods for Achilles Tendon Rupture

Not Applicable

• Conditions: Achilles Tendon Rupture
• Interventions: Procedure: sewed indirectly; Procedure: sewed directly

• Registration Number: NCT01622179
• Lead Sponsor: Peifu Tang

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-19
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-20
• Primary Completion: 2013-05
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Indirectly	sewed indirectly	The epitenon was repaired and sewed indirectly.
Directly	sewed directly	The epitenon was unrepaired and sewed directly.

Primary Outcome Measures

Name	Time	Method
Blood supply condition	six weeks	Blood supply was estimated by ultrasonic contrast at six weeks after surgery.

Secondary Outcome Measures

Name	Time	Method
Calf circumference	six weeks	Calf circumference was measured at six weeks after surgery.
Complications	six months	Infection and rerupture at six month after surgery.

Trial Locations

Locations (1)

Orthopedics department; The General Hospital of the People's Liberation Army; 🇨🇳 Beijing, Beijing, China