Back to resultsOutcome of Two Different Suture Methods for Achilles Tendon Rupture
Primary Purpose
Achilles Tendon Rupture
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sewed indirectly
sewed directly
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring surgery, suture method, blood supply
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.
Sites / Locations
- Orthopedics department; The General Hospital of the People's Liberation ArmyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Indirectly
Directly
Arm Description
The epitenon was repaired and sewed indirectly.
The epitenon was unrepaired and sewed directly.
Outcomes
Primary Outcome Measures
Blood supply condition
Blood supply was estimated by ultrasonic contrast at six weeks after surgery.
Secondary Outcome Measures
Calf circumference
Calf circumference was measured at six weeks after surgery.
Complications
Infection and rerupture at six month after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peifu Tang
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
surgery, suture method, blood supply
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Indirectly
Arm Type
Experimental
Arm Description
The epitenon was repaired and sewed indirectly.
Arm Title
Directly
Arm Type
Placebo Comparator
Arm Description
The epitenon was unrepaired and sewed directly.
Intervention Type
Procedure
Intervention Name(s)
sewed indirectly
Intervention Description
The epitenon was repaired and sewed indirectly.
Intervention Type
Procedure
Intervention Name(s)
sewed directly
Intervention Description
The epitenon was unrepaired and sewed directly.
Primary Outcome Measure Information:
Title
Blood supply condition
Description
Blood supply was estimated by ultrasonic contrast at six weeks after surgery.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Calf circumference
Description
Calf circumference was measured at six weeks after surgery.
Time Frame
six weeks
Title
Complications
Description
Infection and rerupture at six month after surgery.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tang P Fu, Dr.
Phone
861099638101
Email
pftang301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang L Hai, Dr.
Phone
861099638102
Email
zhanglihai74@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang P Fu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedics department; The General Hospital of the People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang P Fu, Dr.
Phone
861099638101
Email
pftang301@126.com
First Name & Middle Initial & Last Name & Degree
Zhang L Hai, Dr.
12. IPD Sharing Statement
Learn more about this trial
Outcome of Two Different Suture Methods for Achilles Tendon Rupture
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