## Protocol Section
### Identification Module
**NCT ID:** NCT01622179

**Brief Title:** Outcome of Two Different Suture Methods for Achilles Tendon Rupture

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

#### Organization Study ID Info
**ID:** PLAGH OD 13
#### Organization
**Class:** OTHER
**Full Name:** Chinese PLA General Hospital
### Status Module
#### Completion Date
**Date:** 2013-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-02-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-02-19

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-06

**Status Verified Date:** 2013-02

#### Study First Post Date
**Date:** 2012-06-19
**Type:** ESTIMATED
**Study First Submit Date:** 2012-06-05
**Study First Submit QC Date:** 2012-06-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peifu Tang

#### Responsible Party

**Investigator Affiliation:** Chinese PLA General Hospital

**Investigator Full Name:** Peifu Tang

**Investigator Title:** Chief, Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Achilles Tendon Rupture

**Keywords:**

- surgery

- suture method

- blood supply

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The epitenon was repaired and sewed indirectly.

**Intervention Names:**

- Procedure: sewed indirectly

**Label:** Indirectly

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The epitenon was unrepaired and sewed directly.

**Intervention Names:**

- Procedure: sewed directly

**Label:** Directly

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Indirectly

**Description:** The epitenon was repaired and sewed indirectly.

**Name:** sewed indirectly

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Directly

**Description:** The epitenon was unrepaired and sewed directly.

**Name:** sewed directly

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Blood supply was estimated by ultrasonic contrast at six weeks after surgery.

**Measure:** Blood supply condition

**Time Frame:** six weeks

#### Secondary Outcomes

**Description:** Calf circumference was measured at six weeks after surgery.

**Measure:** Calf circumference

**Time Frame:** six weeks

**Description:** Infection and rerupture at six month after surgery.

**Measure:** Complications

**Time Frame:** six months

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** pftang301@126.com

**Name:** Tang P Fu, Dr.

**Phone:** 861099638101

**Role:** CONTACT

**Contact 2:**

**Email:** zhanglihai74@yahoo.com.cn

**Name:** Zhang L Hai, Dr.

**Phone:** 861099638102

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** pftang301@126.com

- **Name:** Tang P Fu, Dr.

- **Phone:** 861099638101

- **Role:** CONTACT

***Contact 2:***

- **Name:** Zhang L Hai, Dr.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

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

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100853

#### Overall Officials

**Official 1:**

**Affiliation:** Chinese PLA General Hospital

**Name:** Tang P Fu

**Role:** STUDY_CHAIR

## Annotation Section

### Unposted Annotation

#### Event: RELEASE

- Date: 2015-02-04

- Date Unknown: Unknown

#### Event: RESET

- Date: 2015-02-20

- Date Unknown: Unknown

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15241

- Name: Rupture

- Relevance: HIGH

- As Found: Rupture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012421

- Term: Rupture

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2015-02-04

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2015-02-04

- Reset Date: 2015-02-20

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
