Outcome of Two Different Suture Methods for Achilles Tendon Rupture

Peifu Tang

Status: Unknown

Conditions: Achilles Tendon Rupture

Treatments: Procedure: sewed directly; Procedure: sewed indirectly

Study type: Interventional

Funder types: Other

Identifiers

NCT01622179

PLAGH OD 13

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Indirectly

Experimental group

Description:

The epitenon was repaired and sewed indirectly.

Treatment:

Procedure: sewed indirectly

Directly

Placebo Comparator group

Description:

The epitenon was unrepaired and sewed directly.

Treatment:

Procedure: sewed directly