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Outcome of Two Different Suture Methods for Achilles Tendon Rupture

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ClinicalTrials.gov Identifier: NCT01622179
Recruitment Status : Unknown
Verified February 2013 by Peifu Tang, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : June 19, 2012
Last Update Posted : February 20, 2013
Information provided by (Responsible Party):
Peifu Tang, Chinese PLA General Hospital

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

Condition or disease Intervention/treatment
Achilles Tendon Rupture 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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Closed Achilles Tendon Rupture Treats by Two Different Suture Methods and the Outcome
Study Start Date : June 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Blood supply condition [ Time Frame: six weeks ]
    Blood supply was estimated by ultrasonic contrast at six weeks after surgery.

Secondary Outcome Measures :
  1. Calf circumference [ Time Frame: six weeks ]
    Calf circumference was measured at six weeks after surgery.

  2. Complications [ Time Frame: six months ]
    Infection and rerupture at six month after surgery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622179

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

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
Study Chair: Tang P Fu Chinese PLA General Hospital

Responsible Party: Peifu Tang, Chief, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01622179     History of Changes
Other Study ID Numbers: PLAGH OD 13
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Peifu Tang, Chinese PLA General Hospital:
suture method
blood supply

Additional relevant MeSH terms:
Wounds and Injuries