Outcome of Two Different Suture Methods for Achilles Tendon Rupture

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Peifu Tang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01622179
First received: June 5, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Achilles Tendon Rupture
Procedure: sewed indirectly
Procedure: sewed directly

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome

Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Blood supply condition [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    Blood supply was estimated by ultrasonic contrast at six weeks after surgery.


Secondary Outcome Measures:
  • Calf circumference [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
    Calf circumference was measured at six weeks after surgery.

  • Complications [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    Infection and rerupture at six month after surgery.


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622179

Contacts
Contact: Tang P Fu, Dr. 861099638101 pftang301@126.com
Contact: Zhang L Hai, Dr. 861099638102 zhanglihai74@yahoo.com.cn

Locations
China, Beijing
Orthopedics department; The General Hospital of the People's Liberation Army Recruiting
Beijing, Beijing, China, 100853
Contact: Tang P Fu, Dr.    861099638101    pftang301@126.com   
Principal Investigator: Zhang L Hai, Dr.         
Sponsors and Collaborators
Peifu Tang
Investigators
Study Chair: Tang P Fu Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Peifu Tang, Chief, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01622179     History of Changes
Other Study ID Numbers: PLAGH OD 13
Study First Received: June 5, 2012
Last Updated: February 19, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
surgery
suture method
blood supply

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on October 20, 2014