Outcome of Two Different Suture Methods for Achilles Tendon Rupture

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01622179
• Other study ID #: PLAGH OD 13
• Status: Unknown status
• Phase: N/A
• First received: June 5, 2012
• Last updated: February 19, 2013
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2013
• Source: Chinese PLA General Hospital
• Contact: Tang P Fu, Dr.
• Phone: 861099638101
• Email: pftang301[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Procedure:
• sewed indirectly
The epitenon was repaired and sewed indirectly.
• sewed directly
The epitenon was unrepaired and sewed directly.

Locations

Country	Name	City	State
China	Orthopedics department; The General Hospital of the People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peifu Tang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood supply condition	Blood supply was estimated by ultrasonic contrast at six weeks after surgery.	six weeks
Secondary	Calf circumference	Calf circumference was measured at six weeks after surgery.	six weeks
Secondary	Complications	Infection and rerupture at six month after surgery.	six months