Outcome of Two Different Suture Methods for Achilles Tendon Rupture

NCT ID: NCT01622179

Last Updated: 2013-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

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.

Conditions

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Achilles Tendon Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Indirectly

The epitenon was repaired and sewed indirectly.

Group Type EXPERIMENTAL

sewed indirectly

Intervention Type PROCEDURE

The epitenon was repaired and sewed indirectly.

Directly

The epitenon was unrepaired and sewed directly.

Group Type PLACEBO_COMPARATOR

sewed directly

Intervention Type PROCEDURE

The epitenon was unrepaired and sewed directly.

Interventions

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sewed indirectly

The epitenon was repaired and sewed indirectly.

Intervention Type PROCEDURE

sewed directly

The epitenon was unrepaired and sewed directly.

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peifu Tang

OTHER

Sponsor Role lead

Responsible Party

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Peifu Tang

Chief, Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tang P Fu

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Orthopedics department; The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tang P Fu, Dr.

Role: CONTACT

861099638101

Zhang L Hai, Dr.

Role: CONTACT

861099638102

Facility Contacts

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Tang P Fu, Dr.

Role: primary

861099638101

Other Identifiers

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PLAGH OD 13

Identifier Type: -

Identifier Source: org_study_id

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