Outcome of Two Different Suture Methods for Achilles Tendon Rupture

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

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

Study Overview

• Status: Unknown
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Procedure: sewed indirectly; Procedure: sewed directly

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tang P Fu, Dr.; Phone Number: 861099638101; Email: pftang301@126.com
• Study Contact Backup: Name: Zhang L Hai, Dr.; Phone Number: 861099638102; Email: zhanglihai74@yahoo.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Orthopedics department; The General Hospital of the People's Liberation Army
      • Contact: Tang P Fu, Dr.; Phone Number: 861099638101; Email: pftang301@126.com
      • Principal Investigator: Zhang L Hai, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indirectly; The epitenon was repaired and sewed indirectly.	Procedure: sewed indirectly; The epitenon was repaired and sewed indirectly.
Placebo Comparator: Directly; The epitenon was unrepaired and sewed directly.	Procedure: sewed directly; The epitenon was unrepaired and sewed directly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood supply condition	Blood supply was estimated by ultrasonic contrast at six weeks after surgery.	six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calf circumference	Calf circumference was measured at six weeks after surgery.	six weeks
Complications	Infection and rerupture at six month after surgery.	six months

Collaborators and Investigators

• Sponsor: Peifu Tang
• Investigators: Study Chair: Tang P Fu, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: surgery; suture method; blood supply
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: PLAGH OD 13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No